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Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI) (HOPPS)

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ClinicalTrials.gov Identifier: NCT01306968
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : September 5, 2014
Last Update Posted : September 5, 2014
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: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Post-concussive Symptoms
Traumatic Brain Injury
Interventions Drug: hyperbaric oxygen
Other: sham hyperbaric air
Enrollment 79
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Hide Arm/Group Description Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen. Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.

Period Title: Overall Study
Started 7 23 24 25 [1]
Completed 6 20 23 21
Not Completed 1 3 1 4
Reason Not Completed
Lost to Follow-up             1             1             0             0
Physician Decision             0             1             0             0
Relocated and left active duty             0             1             1             1
Withdrew - time commitment             0             0             0             2
Withdrew over privacy concerns             0             0             0             1
[1]
2 participants withdrew before chamber sessions were initiated
Arm/Group Title PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group Total
Hide Arm/Group Description Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen. Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.

Total of all reporting groups
Overall Number of Baseline Participants 7 23 24 25 79
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 23 participants 24 participants 25 participants 79 participants
33.0  (9.0) 30.3  (7.2) 32.5  (7.9) 31.4  (7.6) 31.6  (7.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 23 participants 24 participants 25 participants 79 participants
Female
1
  14.3%
1
   4.3%
1
   4.2%
1
   4.0%
4
   5.1%
Male
6
  85.7%
22
  95.7%
23
  95.8%
24
  96.0%
75
  94.9%
Post-concussion Symptom Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 7 participants 23 participants 24 participants 25 participants 79 participants
RPQ-3 2.7  (1.89) 5.4  (2.74) 5.5  (3.27) 4.7  (3.09) 5.0  (3.01)
RPQ-13 20.9  (9.19) 27.1  (12.20) 27.5  (13.15) 25.5  (11.61) 26.2  (12.02)
RPQ Total 23.6  (10.11) 32.5  (14.39) 33.0  (15.82) 30.2  (14.17) 31.1  (14.55)
[1]
Measure Description: The Rivermead Post-Concussion Symptom Questionnaire (RPQ) was created to measure the severity of post-concussion symptoms following traumatic brain injury (TBI). RPQ-3 are the first 3 symptoms of the RPQ Total including headaches, dizziness, and nausea/vomiting. RPQ-13 are the remaining 13 TBI symptoms. Using values of 0 (not experienced at all), 1 (no more of a problem than before the injury), 2 (mild problem), 3 (moderate problem), or 4 (severe problem). The range is 0 to 64. The score is a summation of symptoms rated as >2 representing new symptom onset or exacerbation of symptom(s).
1.Primary Outcome
Title Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat
Hide Description The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The 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 outcome 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.
Time Frame Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population: All randomized participants were included in the intention-to-treat analysis.
Arm/Group Title PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Hide Arm/Group Description:
Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.

Overall Number of Participants Analyzed 6 20 23 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
RPQ-3 3.5  (3.21) 5.1  (2.81) 4.2  (3.00) 3.5  (3.25)
RPQ-13 19.7  (13.06) 25.5  (13.93) 22.5  (12.35) 20.7  (12.82)
Total RPQ 23.2  (16.04) 30.6  (16.08) 26.7  (24.83) 24.2  (15.38)
2.Primary Outcome
Title Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat
Hide Description Means for the change from baseline to follow-up visit 2
Time Frame Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population: All randomized participants were included in the intention-to-treat analysis
Arm/Group Title PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Hide Arm/Group Description:
Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) Follow-up visit 2 = Day 56 (up to day 100)

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.

Overall Number of Participants Analyzed 6 20 23 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
RPQ-3 0.3  (2.73) 0.0  (2.05) -1.2  (2.81) -1.5  (3.01)
RPQ-13 -3.0  (15.39) -0.5  (9.65) -4.2  (11.42) -5.5  (10.50)
Total RPQ -2.7  (17.88) -0.5  (11.32) -5.4  (13.66) -7.0  (12.97)
3.Primary Outcome
Title Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population
Hide Description The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The 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 outcome 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.
Time Frame Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.
Arm/Group Title PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Hide Arm/Group Description:
Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.

Overall Number of Participants Analyzed 6 20 11 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
RPQ-3 3.5  (3.21) 5.1  (2.81) 3.1  (2.21) 2.7  (2.84)
RPQ-13 19.7  (13.06) 25.5  (13.93) 15.6  (10.93) 17.4  (13.25)
Total RPQ 23.2  (16.04) 30.6  (16.08) 18.7  (12.96) 20.1  (15.67)
4.Primary Outcome
Title Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population
Hide Description The Rivermead Post-Concussion Symptom Questionnaire (RPQ)/RPQ-3 was created to measure the severity of post-concussion symptoms following traumatic brain injury. The 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 outcome 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.
Time Frame Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol population: Only those completing all 40 chamber sessions and outcomes testing are included in the per protocol population. The standard TBI care group remained the same as no champber sessions were use in this group.
Arm/Group Title PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Hide Arm/Group Description:
Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.

Overall Number of Participants Analyzed 6 20 11 13
Mean (Standard Deviation)
Unit of Measure: units on a scale
RPQ-3 0.3  (2.73) 0.0  (2.05) -1.6  (2.54) -2.2  (2.44)
RPQ-13 -3.0  (15.39) -0.5  (9.65) -9.4  (9.68) -8.5  (9.44)
Total RPQ -2.7  (17.88) -0.5  (11.32) -11.0  (11.64) -10.7  (11.22)
Time Frame Within 14 days of the last chamber session
Adverse Event Reporting Description Standard TBI Care and PTSD with no history of TBI groups recieved no HBO2 exposure and were not at risk for chamber intervention related injury. 2 participants withdrew before chamber sessions were initiated. Safety population of HBO2 (n=24) and sham (n=23)
 
Arm/Group Title PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Hide Arm/Group Description Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen. Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)

Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday

hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.

The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens ("door-to-door" time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute).

Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)

sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.

All-Cause Mortality
PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      0/24 (0.00%)      0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4.2%
PTSD With no History of TBI Standard TBI Care HBO2 Group Sham Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      8/24 (33.33%)      6/23 (26.09%)    
Ear and labyrinth disorders         
mild ear pain *  0/0  0 0/0  0 1/24 (4.17%)  1 1/23 (4.35%)  1
Inner ear barotrauma *  0/0  0 0/0  0 3/24 (12.50%)  3 0/23 (0.00%)  0
Eye disorders         
Transient worsening of myopia *  0/0  0 0/0  0 1/24 (4.17%)  1 0/23 (0.00%)  0
General disorders         
Tooth pain *  0/0  0 0/0  0 1/24 (4.17%)  1 0/23 (0.00%)  0
Onset migraine headache *  0/0  0 0/0  0 1/24 (4.17%)  1 0/23 (0.00%)  0
Increase frequency and intensity of headaches *  0/0  0 0/0  0 1/24 (4.17%)  1 0/23 (0.00%)  0
Change in headache frequency *  0/0  0 0/0  0 0/24 (0.00%)  0 1/23 (4.35%)  1
Claustrophobia/anxiety *  0/0  0 0/0  0 0/24 (0.00%)  0 1/23 (4.35%)  1
Sinus pain *  0/0  0 0/0  0 0/24 (0.00%)  0 3/23 (13.04%)  3
*
Indicates events were collected by non-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
Layout table for Results Point of Contact information
Name/Title: Dr. R. Scott Miller, M.D.
Organization: Uniformed Services University of Health Sciences
Phone: 301-816-8424
EMail: robert.s.miller@us.army.mil
Layout table for additonal information
Responsible Party: U.S. Army Medical Research and Development Command
ClinicalTrials.gov Identifier: NCT01306968     History of Changes
Other Study ID Numbers: S-10-09
First Submitted: February 24, 2011
First Posted: March 2, 2011
Results First Submitted: July 16, 2014
Results First Posted: September 5, 2014
Last Update Posted: September 5, 2014