Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI) (HBOT)

This study has been completed.
Sponsor:
Collaborators:
United States Naval Medical Center, Portsmouth
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01220713
First received: October 6, 2010
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

The goal of this research is to serve as a demonstration project to determine the tolerability of individuals with persistent post-concussive symptoms from combat-related mild TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen) therapy, and determine the efficacy of HBO2 therapy.


Condition Intervention Phase
Mild Traumatic Brain Injury
Post-Concussive Syndrome
Procedure: Hyperbaric Oxygen Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI): A Randomized, Double-Blinded, Sham Controlled, Variable Dose, Prospective Trial

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Improvement on symptom assessment battery [ Time Frame: 2-4 weeks before treatment ] [ Designated as safety issue: No ]
    Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale

  • Improvement on symptom assessment battery [ Time Frame: 24-72 hours after final treatment ] [ Designated as safety issue: No ]
    Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale

  • Improvement on symptom assessment battery [ Time Frame: 3 months after final treatment. ] [ Designated as safety issue: No ]
    Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale


Secondary Outcome Measures:
  • Neuropsychological Testing Battery [ Time Frame: 2-4 weeks before treatment ] [ Designated as safety issue: No ]
    Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised

  • Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging and Eye tracking [ Time Frame: 24-72 hours after final treatment ] [ Designated as safety issue: No ]
  • Common Military Task Tests [ Time Frame: 2-4 weeks before treatment ] [ Designated as safety issue: No ]
    Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock

  • Neuropsychological Testing Battery [ Time Frame: 24-72 hours after final treatment ] [ Designated as safety issue: No ]
    Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised

  • Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking [ Time Frame: 3 months after final treatment. ] [ Designated as safety issue: No ]
  • Neuropsychological Testing Battery [ Time Frame: 3 months after final treatment. ] [ Designated as safety issue: No ]
    Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised

  • Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking [ Time Frame: 2-4 weeks before treatment ] [ Designated as safety issue: No ]
  • Common Military Task Tests [ Time Frame: 24-72 hours after final treatment ] [ Designated as safety issue: No ]
    Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock

  • Common Military Task Tests [ Time Frame: 3 months after final treatment. ] [ Designated as safety issue: No ]
    Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock


Enrollment: 60
Study Start Date: June 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1--1.5 atm abs Procedure: Hyperbaric Oxygen Therapy
1.5 atm abs oxygen equivalent of 75% oxygen (balance 25% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Experimental: Treatment 2--2.0 atm abs Procedure: Hyperbaric Oxygen Therapy
2.0 atm abs oxygen equivalent of 100% oxygen (no nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Sham Comparator: Placebo--equivalent to breathing air Procedure: Hyperbaric Oxygen Therapy
sham--air equivalent of 10.5% oxygen (balance 89.5% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.

Detailed Description:

Persistent post-concussive symptoms from mild traumatic brain injury are a severe issue facing the readiness, retention and quality of life of Department of Defense(DoD) service members and Veterans. The inadequacy of established treatment regimens and evidence-based science in post-concussive symptoms (PCS)/MTBI is forcing a closer look at non-conventional treatments of this condition. Hyperbaric oxygen (HBO2) is a potent intervention with demonstrated efficacy in dive-related injuries, soft tissue healing, and carbon monoxide poisoning.

This study is prospective, randomized, double-blinded and controlled. A total of 60 subjects will be randomly assigned to one of three treatment arms of the study: 20 subjects into the 1.5 atm abs oxygen equivalent HBO2 treatment, 20 subjects into the 2.0 atm abs oxygen equivalent HBO2 treatment and 20 subjects into the sham treatment (a placebo exposure equivalent to breathing atmospheric air). The protocol utilizes a pre- and post-treatment comprehensive performance battery that will allow for meaningful clinical outcomes and a broad understanding of the effects of the treatment. This project represents a collaboration between the Department of Defense (DoD), the Richmond Veterans Administration Medical Center (VAMC) and Virginia Commonwealth University. Service members will be recruited from military bases/treatment facilities (MTF), receive hyperbaric oxygen at existing DoD hyperbaric chambers and be evaluated by the established Virginia Commonwealth University-Center for Rehabilitation Sciences and Engineering (CERSE), a collaborative research center co-located at the Richmond VAMC and VCU.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Post-Deployment status after having served in OIF/OEF
  2. Blast Event within past 3 years during OIF/OEF deployment [event defined as any of the following symptoms or experiences occurring during or shortly after the blast or explosion: dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), hearing loss, abdominal pain, shortness of breath, struck by debris, knocked over or down, knocked into or against something, helmet damaged, evacuated]
  3. Diagnosis of MTBI within 3 years as confirmed by the TBI specialty team at the Richmond VAMC
  4. Presence of post-concussive symptoms from MTBI, confirmed by the VCU-CERSE team at the Richmond VAMC, for at least 3 months
  5. Medical clearance to undergo hyperbaric oxygen treatment
  6. Stable mental status for at least one month
  7. Stable psychotropic medication history for at least one month
  8. Ability to perform neuropsychologic testing battery
  9. Ability to tolerate neurophysiological and neuroimaging battery

Exclusion Criteria:

  1. Traumatic Brain Injury with a primary etiology other than blast
  2. Moderate or Severe TBI (moderate or severe brain injury defined as best Glasgow Coma Score in first 24 hours < 12, , brain bleeding or blood clot (i.e., abnormal brain CT scan), or none of first week after event can be remembered.)
  3. Past history of moderate or severe TBI
  4. Active diagnosis of Post-traumatic Stress Disorder
  5. Active diagnosis of Generalized Anxiety Disorder
  6. Active Psychosis
  7. Past history of Schizophrenia
  8. Pre-existing PCS
  9. Previous hyperbaric oxygen treatments
  10. Contraindications to HBO2, including any "air trapping" pulmonary problems, inability to equalize middle ear and sinuses, or patients who are claustrophobic and require anti-anxiety medication for the condition
  11. Active use of cancer medications
  12. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01220713

Locations
United States, Virginia
Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Hunter Holmes McGuire Veterans' Affairs Medical Center
Richmond, Virginia, United States
Sponsors and Collaborators
Virginia Commonwealth University
United States Naval Medical Center, Portsmouth
Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
Principal Investigator: David X Cifu, MD Virginia Commonwealth University
Principal Investigator: Brett Hart, MD Naval Operational Medicine Institute
Principal Investigator: Michelle Nichols, MSN, RN McGuire Veterans' Affairs Medical Center
Study Director: Justin O Alicea Virginia Commonwealth University
Study Director: Steven L West, PhD Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01220713     History of Changes
Other Study ID Numbers: N66001-09-2-2060, 01609, NOMI.2010.002, HM12204
Study First Received: October 6, 2010
Last Updated: August 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
Traumatic Brain Injury
Veterans
Hyperbaric Oxygen Treatment
OEF/OIF
Post-Concussive Symptoms
Blast Exposure

Additional relevant MeSH terms:
Brain Concussion
Brain Injuries
Post-Concussion Syndrome
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on August 28, 2014