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mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms (BIMA)

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ClinicalTrials.gov Identifier: NCT01611194
Recruitment Status : Completed
First Posted : June 4, 2012
Results First Posted : November 21, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Development Command

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Conditions Traumatic Brain Injury With Brief Loss of Consciousness
Post-Concussion Syndrome
Interventions Drug: Hyperbaric oxygen (HBO2) at 1.5 atms
Drug: Sham control 1.2 atms
Enrollment 71
Recruitment Details Participants were recruited from military sites from Sept 2012 to May 2014.
Pre-assignment Details  
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Period Title: Overall Study
Started 36 35
Completed 36 32
Not Completed 0 3
Reason Not Completed
Lost to Follow-up             0             1
Withdrawal by Subject             0             1
drug use             0             1
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres) Total
Hide Arm/Group Description

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Total of all reporting groups
Overall Number of Baseline Participants 36 35 71
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants 35 participants 71 participants
34.8  (8.3) 30.8  (5.5) 32.8  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Female
0
   0.0%
1
   2.9%
1
   1.4%
Male
36
 100.0%
34
  97.1%
70
  98.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Hispanic or Latino
7
  19.4%
6
  17.1%
13
  18.3%
Not Hispanic or Latino
29
  80.6%
29
  82.9%
58
  81.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.9%
1
   1.4%
Native Hawaiian or Other Pacific Islander
2
   5.6%
2
   5.7%
4
   5.6%
Black or African American
2
   5.6%
2
   5.7%
4
   5.6%
White
30
  83.3%
28
  80.0%
58
  81.7%
More than one race
0
   0.0%
1
   2.9%
1
   1.4%
Unknown or Not Reported
2
   5.6%
1
   2.9%
3
   4.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 36 participants 35 participants 71 participants
36
 100.0%
35
 100.0%
71
 100.0%
Education  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Less than high school diploma
0
   0.0%
0
   0.0%
0
   0.0%
High school diploma
7
  19.4%
6
  17.1%
13
  18.3%
Some college
13
  36.1%
23
  65.7%
36
  50.7%
College degree
11
  30.6%
5
  14.3%
16
  22.5%
Graduare degree
5
  13.9%
1
   2.9%
6
   8.5%
Military Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Active duty
35
  97.2%
33
  94.3%
68
  95.8%
Veteran
1
   2.8%
2
   5.7%
3
   4.2%
Time From Most Recent Qualifying Mild Traumatic Brain Injury (mTBI)  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 36 participants 35 participants 71 participants
25.6  (17.1) 25.5  (15.4) 25.6  (16.2)
Most Recent Qualifying mTBI 3 Months to 1 Year  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
3 months to 1 year
12
  33.3%
8
  22.9%
20
  28.2%
>1year to 5 years
24
  66.7%
27
  77.1%
51
  71.8%
Number of Lifetime mTBIs  
Mean (Standard Deviation)
Unit of measure:  mTBIs
Number Analyzed 36 participants 35 participants 71 participants
3.6  (3.2) 3.7  (2.3) 3.6  (2.8)
Lifetime mTBI History  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Blast injuries
15
  41.7%
8
  22.9%
23
  32.4%
Blunt force head injuries only
7
  19.4%
7
  20.0%
14
  19.7%
Combination of blast and blunt force injuries
14
  38.9%
20
  57.1%
34
  47.9%
Most Recent Qualifying Injury  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Blast injury
23
  63.9%
23
  65.7%
46
  64.8%
Blunt force head injury
13
  36.1%
12
  34.3%
25
  35.2%
Military Rank  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
E1-E10
31
  86.1%
35
 100.0%
66
  93.0%
O-1 to O-10/W-1 to W-5
5
  13.9%
0
   0.0%
5
   7.0%
Military Branch  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Army
27
  75.0%
28
  80.0%
55
  77.5%
Marines
7
  19.4%
5
  14.3%
12
  16.9%
Navy, Air Force, and Coast Guard
2
   5.6%
2
   5.7%
4
   5.6%
Number of Combat Deployments  
Mean (Standard Deviation)
Unit of measure:  Deployments
Number Analyzed 36 participants 35 participants 71 participants
3.4  (2.8) 2.2  (1.7) 2.8  (2.4)
Common Medication Usage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
SSRI/SNRIs 12 10 22
Hypnotic or sleep aid 16 15 31
Daily pain medication 22 21 43
Episodic migraine medication 16 14 30
Fish oil or omega-3 fatty acid 9 8 17
Common Alternative Therapy Usage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 36 participants 35 participants 71 participants
Psychotherapy 12 7 19
Counseling 16 12 28
Physical therapy 14 20 34
1.Primary Outcome
Title Summary of Treatment-Emergent Adverse Events
Hide Description Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.
Time Frame months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Measure Type: Count of Participants
Unit of Measure: Participants
Barotitis media
13
  36.1%
5
  14.3%
Sinus barotrauma
5
  13.9%
3
   8.6%
Contusion
3
   8.3%
3
   8.6%
Ligament sprain
0
   0.0%
5
  14.3%
Muscle strain
1
   2.8%
3
   8.6%
Upper respiratory tract infection
13
  36.1%
9
  25.7%
Gastroenteritis
1
   2.8%
5
  14.3%
Sinusitis
3
   8.3%
4
  11.4%
Nasopharyngitis
3
   8.3%
2
   5.7%
Arthralgia
4
  11.1%
2
   5.7%
Back pain
3
   8.3%
2
   5.7%
Neck pain
0
   0.0%
4
  11.4%
Dizziness
5
  13.9%
1
   2.9%
Headache
4
  11.1%
2
   5.7%
Nasal congestion
5
  13.9%
3
   8.6%
Dyspnea
4
  11.1%
1
   2.9%
Epistaxis
2
   5.6%
2
   5.7%
Sinus congestion
2
   5.6%
2
   5.7%
Eye disorders
10
  27.8%
7
  20.0%
Nausea
4
  11.1%
1
   2.9%
Suicidal ideation
2
   5.6%
2
   5.7%
Rash
0
   0.0%
3
   8.6%
Investigations
4
  11.1%
3
   8.6%
Vertigo
3
   8.3%
3
   8.6%
General and administration site conditions
3
   8.3%
1
   2.9%
Metabolism and nutrition disorders
3
   8.3%
2
   5.7%
Renal and urinary disorders
3
   8.3%
0
   0.0%
Vascular disorders
3
   8.3%
0
   0.0%
Congenital, familial and genetic disorders
1
   2.8%
0
   0.0%
Endocrine disorders
1
   2.8%
0
   0.0%
Hepatobiliary disorders
1
   2.8%
0
   0.0%
Immune system disorders
0
   0.0%
1
   2.9%
Neoplasms benign, malignant and unspecified
0
   0.0%
1
   2.9%
2.Primary Outcome
Title Summary of Study Intervention-Related Adverse Events
Hide Description Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.
Time Frame months 3, 6, 4, 5 and 7-12. Extended f/u up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Measure Type: Count of Participants
Unit of Measure: Participants
Barotitis media
11
  30.6%
5
  14.3%
Sinus barotrauma
5
  13.9%
4
  11.4%
Dizziness
1
   2.8%
1
   2.9%
Headache
1
   2.8%
2
   5.7%
Somnolence
1
   2.8%
1
   2.9%
Dyspnea
2
   5.6%
0
   0.0%
Hyperventilation
1
   2.8%
0
   0.0%
Anxiety
1
   2.8%
0
   0.0%
Myopia
1
   2.8%
1
   2.9%
Eye pruritus
0
   0.0%
1
   2.9%
Vertigo
1
   2.8%
1
   2.9%
3.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (ITT Population)
Hide Description RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: RPQ scores
RPQ Total Score 34.8  (13.1) 28.2  (13.5)
RPQ-3 Score 5.8  (2.9) 4.5  (2.6)
RPQ-13 Score 29.0  (11.0) 23.7  (11.4)
4.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ, RPQ3 and RPQ13) - Baseline (Per Protocol (PP) Population)
Hide Description RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-3 and RPQ-13 domain scores are presented separately. For each of the RPQ-3, RPQ-13, and RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: RPQ scores
RPQ Total Score 34.7  (13.3) 27.3  (12.9)
RPQ-3 Score 5.8  (2.9) 4.5  (2.5)
RPQ-13 Score 28.9  (11.1) 22.8  (11.0)
5.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (ITT Population)
Hide Description RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. The scores were derived by totaling the corresponding question scores for each domain and it's change from baseline.
Time Frame Baseline to week 13, Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Week 13 change score Number Analyzed 36 participants 35 participants
-0.7  (14.6) 5.8  (12.4)
Month 6 change score Number Analyzed 35 participants 32 participants
-4.3  (14.0) 2.6  (11.6)
Month 12 change score Number Analyzed 34 participants 31 participants
5.7  (14.7) 5.5  (12.4)
6.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (ITT Population)
Hide Description RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and it's change from baseline.
Time Frame Baseline to week 13, Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Week 13 change score Number Analyzed 36 participants 35 participants
-0.3  (2.7) 1.2  (2.2)
Month 6 change score Number Analyzed 35 participants 32 participants
-1.4  (2.7) 0.3  (2.2)
Month 12 change score Number Analyzed 35 participants 31 participants
0.5  (2.9) 0.5  (2.6)
7.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (ITT Population)
Hide Description RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to week 13, Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
1 subject in HBO2 missed the 6 month visit and 2 subjects missed the 12 month visit. 1 subject in the sham missed the week 13 visit and, 1 subject missed the month 6 visit and 3 subjects withdrew by month 12
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Week 13 change score Number Analyzed 36 participants 35 participants
-0.4  (12.3) 4.7  (11.1)
Month 6 change score Number Analyzed 35 participants 32 participants
-3.0  (11.9) 2.3  (9.9)
Month 12 change score Number Analyzed 34 participants 31 participants
5.2  (12.7) 5.0  (10.4)
8.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population)
Hide Description RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to week 13, Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Week 13 change score Number Analyzed 35 participants 32 participants
-1.0  (14.7) 6.1  (12.6)
Month 6 change score Number Analyzed 35 participants 31 participants
-4.3  (14.0) 3.2  (11.3)
Month 12 change score Number Analyzed 33 participants 30 participants
5.8  (14.9) 5.5  (12.6)
9.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population)
Hide Description RPQ/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. For the RPQ-3total scale, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to week 13, Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Week 13 change score Number Analyzed 35 participants 32 participants
-0.4  (2.8) 1.2  (2.3)
Month 6 change score Number Analyzed 35 participants 31 participants
-1.4  (2.7) 0.3  (2.2)
Month 12 change score Number Analyzed 34 participants 30 participants
0.4  (2.9) 0.5  (2.7)
10.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population)
Hide Description RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. The scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to week 13, Months 6 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Week 13 change score Number Analyzed 35 participants 32 participants
-0.7  (12.4) 4.9  (11.2)
Month 6 change score Number Analyzed 35 participants 31 participants
-3.0  (11.9) 2.9  (9.5)
Month 12 change score Number Analyzed 33 participants 30 participants
5.4  (12.8) 5.1  (10.6)
11.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline: 24 and 36 Months (ITT Population)
Hide Description RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to 24 months and 36 months
Hide Outcome Measure Data
Hide Analysis Population Description

HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.

Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36

Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Baseline to 24 months Number Analyzed 20 participants 15 participants
1.2  (18.5) 2.9  (11.9)
Baseline to 36 months Number Analyzed 8 participants 5 participants
1.4  (9.0) 4.6  (19.6)
12.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline: 24 and 36 Months (ITT Population)
Hide Description RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to 24 months and 36 months
Hide Outcome Measure Data
Hide Analysis Population Description

HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.

Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36

Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Baseline to 24 months Number Analyzed 21 participants 16 participants
-0.2  (3.2) -0.1  (2.7)
Baseline to 36 months Number Analyzed 9 participants 5 participants
-0.9  (2.9) 0.8  (3.0)
13.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline: 24 and 36 Months (ITT Population)
Hide Description RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to 24 months and 36 months
Hide Outcome Measure Data
Hide Analysis Population Description

HBO2: 25 subs consented to 24 and 36 month f/u; 23 subs completed month 24 and 9 completed month 36; 2 subs missed 24 month visit.

Sham: 17 subs consented to 24 and 36 month f/u. 17 completed month 24 and 5 completed month 36

Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 36 35
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Baseline to 24 months Number Analyzed 20 participants 15 participants
1.4  (16.1) 3.0  (9.5)
Baseline to 36 months Number Analyzed 8 participants 5 participants
2.0  (7.5) 3.8  (16.8)
14.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ) - Change From Baseline (Per Protocol (PP) Population)
Hide Description RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. For the RPQ total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to month 24 and month 36
Hide Outcome Measure Data
Hide Analysis Population Description
PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Baseline to month 24 Number Analyzed 20 participants 15 participants
1.2  (18.5) 2.9  (11.9)
Baseline to month 36 Number Analyzed 8 participants 5 participants
1.4  (9.0) 4.6  (19.6)
15.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ3) - Change From Baseline (Per Protocol (PP) Population)
Hide Description RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-3 ranges from 0-12 and access a subset of symptoms. Analyses of the RPQ-3 domain scores are presented separately. For the RPQ-3 total scales, the scores were derived by totaling the corresponding question scores for each domain and change from baseline.
Time Frame Baseline to month 24 and month 36
Hide Outcome Measure Data
Hide Analysis Population Description
PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Baseline to month 24 Number Analyzed 21 participants 16 participants
-0.2  (3.2) -0.1  (2.7)
Baseline to month 36 Number Analyzed 9 participants 5 participants
-0.9  (2.9) 0.8  (3.0)
16.Secondary Outcome
Title Presence of Post Concussion Symptoms Following Traumatic Brain Injury Using The Rivermead Post-Concussion Symptom Questionnaire (RPQ13) - Change From Baseline (Per Protocol (PP) Population)
Hide Description RPQ was created to measure the severity of post-concussion symptoms following traumatic brain injury. Scale compares any current symptoms to pre-injury levels to account for potential symptom exacerbation due to the TBI. The RPQ is the most commonly used clinical measure for mild TBI research because it is simple and reflects psychosocial function. The RPQ is intended to measure the presence and severity of 16 of the most commonly reported post-concussion symptoms found in the literature. The RPQ scale includes 16 common post-concussion symptom items whose responses range from "0= Not experienced at" to "4= A severe problem". Total range is 0 to 64. RPQ-13 ranges from 0-52 and access's 13 remaining symptoms. Analyses of the RPQ-13 domain scores are presented separately. For RPQ-13 total scales, the scores were derived by totaling the corresponding question scores for each domain change from baseline.
Time Frame Baseline to month 24 and month 36
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Hide Analysis Population Description
PP was defined as subs who completed 20 chamber sessions and week13 f/u. PP was also restricted to subs who didn't report illicit drug use following randomization. 67 subs satisfied the PP, 35/36 HBO2 and 32/35 sham. 4 were excluded from the PP population, 3 excluded because they completed <20 sessions,1 because of illicit drug use during study.
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description:

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Overall Number of Participants Analyzed 35 32
Mean (Standard Deviation)
Unit of Measure: RPQ scores
Baseline to month 24 Number Analyzed 20 participants 15 participants
1.4  (16.1) 3.0  (9.5)
Baseline to month 36 Number Analyzed 8 participants 5 participants
2.0  (7.5) 3.8  (16.8)
Time Frame Safety was evaluated in-person during the first 3 months and at month 6, and via telephone follow-up calls at months 4, 5, and 7-12. Extended annual follow-up continued for up to 36 months through January 2016.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Hide Arm/Group Description

Hyperbaric oxygen (HBO2) at 1.5 atms. Stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization.

Hyperbaric oxygen (HBO2) at 1.5 atms: The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham control 1.2 atms. Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

Sham control 1.2 atms: The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).

All-Cause Mortality
HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)      0/35 (0.00%)    
Hide Serious Adverse Events
HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/36 (13.89%)      3/35 (8.57%)    
General disorders     
Pain  1  1/36 (2.78%)  1 0/35 (0.00%)  0
Infections and infestations     
Cellulitis  1  0/36 (0.00%)  0 1/35 (2.86%)  1
Injury, poisoning and procedural complications     
Fall  1  1/36 (2.78%)  1 0/35 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoarthritis  1  1/36 (2.78%)  1 0/35 (0.00%)  0
Psychiatric disorders     
Post-traumatic stress disorder  1  2/36 (5.56%)  2 0/35 (0.00%)  0
Psychotic disorder  1  0/36 (0.00%)  0 1/35 (2.86%)  1
Suicide attempt  1  0/36 (0.00%)  0 1/35 (2.86%)  1
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
HBO2 at 1.5 Atomspheres Absolute (ATA) Sham Control (1.2 Atomspheres)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/36 (97.22%)      34/35 (97.14%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders  1  1/36 (2.78%)  1 0/35 (0.00%)  0
Congenital, familial and genetic disorders     
Congenital, familial and genetic disorders  1  1/36 (2.78%)  1 0/35 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  3/36 (8.33%)  5 3/35 (8.57%)  3
Endocrine disorders     
Endocrine disorders  1  1/36 (2.78%)  1 0/35 (0.00%)  0
Eye disorders     
Eye disorders  1  11/36 (30.56%)  14 7/35 (20.00%)  10
Gastrointestinal disorders     
Nausea  1  4/36 (11.11%)  5 1/35 (2.86%)  2
Hepatobiliary disorders     
Hepatobiliary disorders  1  1/36 (2.78%)  1 0/35 (0.00%)  0
Immune system disorders     
Immune system disorders  1  1/36 (2.78%)  1 1/35 (2.86%)  1
Infections and infestations     
Upper respiratory tract infection  1  16/36 (44.44%)  18 10/35 (28.57%)  13
Gastroenteritis  1  1/36 (2.78%)  1 6/35 (17.14%)  7
Sinusitis  1  4/36 (11.11%)  4 4/35 (11.43%)  4
Nasopharyngitis  1  4/36 (11.11%)  4 3/35 (8.57%)  3
Injury, poisoning and procedural complications     
Barotitis media  1  13/36 (36.11%)  20 6/35 (17.14%)  8
Sinus barotrauma  1  5/36 (13.89%)  10 4/35 (11.43%)  9
Contusion  1  6/36 (16.67%)  8 3/35 (8.57%)  3
Ligament sprain  1  0/36 (0.00%)  0 5/35 (14.29%)  5
Mucsle strain  1  1/36 (2.78%)  1 3/35 (8.57%)  3
Investigations     
Investigations  1  5/36 (13.89%)  7 3/35 (8.57%)  4
Metabolism and nutrition disorders     
Vitamin D deficiency  1  3/36 (8.33%)  3 1/35 (2.86%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  3/36 (8.33%)  5 3/35 (8.57%)  6
Arthralgia  1  4/36 (11.11%)  5 2/35 (5.71%)  3
Neck pain  1  0/36 (0.00%)  0 4/35 (11.43%)  4
Tendonitis  1  1/36 (2.78%)  1 3/35 (8.57%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasms benign, malignant and unspecified  1  0/36 (0.00%)  0 1/35 (2.86%)  1
Nervous system disorders     
Dizziness  1  6/36 (16.67%)  7 1/35 (2.86%)  2
Headache  1  4/36 (11.11%)  4 2/35 (5.71%)  3
Psychiatric disorders     
Suicidal ideation  1  2/36 (5.56%)  2 2/35 (5.71%)  2
Renal and urinary disorders     
Renal and urinary disorders  1  3/36 (8.33%)  4 0/35 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nasal congestion  1  5/36 (13.89%)  5 4/35 (11.43%)  5
Dyspnea  1  4/36 (11.11%)  4 1/35 (2.86%)  1
Epistaxis  1  2/36 (5.56%)  2 2/35 (5.71%)  2
Sinus congestion  1  2/36 (5.56%)  2 2/35 (5.71%)  2
Skin and subcutaneous tissue disorders     
Rash  1  1/36 (2.78%)  2 3/35 (8.57%)  3
General disorders and administration site conditions  1  6/36 (16.67%)  6 1/35 (2.86%)  2
Vascular disorders     
Vascular disorders  1  5/36 (13.89%)  6 0/35 (0.00%)  0
1
Term from vocabulary, MedDRA (Unspecified)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Lindell Weaver, MD, FACP, UHM
Organization: Intermountain Healthcare
Phone: 801-408-3623
EMail: lindell.weaver@imail.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT01611194    
Other Study ID Numbers: S-11-17
First Submitted: May 3, 2012
First Posted: June 4, 2012
Results First Submitted: May 15, 2018
Results First Posted: November 21, 2018
Last Update Posted: November 21, 2018