Mild Traumatic Brain InjuryPhase 2HBOTNCT01220713
Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)
A Phase 2 study testing Hyperbaric Oxygen Therapy in people with Mild Traumatic Brain Injury and Post-Concussive Syndrome, run by Virginia Commonwealth University at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Mild Traumatic Brain Injury, Post-Concussive Syndrome
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2010to Jul 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Post-Deployment status after having served in OIF/OEF
- 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]
- Diagnosis of MTBI within 3 years as confirmed by the TBI specialty team at the Richmond VAMC
- Presence of post-concussive symptoms from MTBI, confirmed by the VCU-CERSE team at the Richmond VAMC, for at least 3 months
- Medical clearance to undergo hyperbaric oxygen treatment
- Stable mental status for at least one month
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- Stable psychotropic medication history for at least one month
- Ability to perform neuropsychologic testing battery
- Ability to tolerate neurophysiological and neuroimaging battery
Who cannot join
- Traumatic Brain Injury with a primary etiology other than blast
- 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.)
- Past history of moderate or severe TBI
- Active diagnosis of Post-traumatic Stress Disorder
- Active diagnosis of Generalized Anxiety Disorder
- Active Psychosis
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- Past history of Schizophrenia
- Pre-existing PCS
- Previous hyperbaric oxygen treatments
- 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
- Active use of cancer medications
- Pregnancy
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Naval Medical Center Portsmouth
Portsmouth, Virginia
Hunter Holmes McGuire Veterans' Affairs Medical Center
Richmond, Virginia
Virginia Commonwealth University
Richmond, Virginia
About this study
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
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.
Read the 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.
- Being tested
- Hyperbaric Oxygen Therapy
- Keywords
- Traumatic Brain Injury, Veterans, Hyperbaric Oxygen Treatment, OEF/OIF, Post-Concussive Symptoms, Blast Exposure
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
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.
Hyperbaric Oxygen TherapyProcedure or surgery
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.
Hyperbaric Oxygen TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1--1.5 atm abs | Experimental | Not described Receives: Procedure: Hyperbaric Oxygen Therapy |
| Treatment 2--2.0 atm abs | Experimental | Not described Receives: Procedure: Hyperbaric Oxygen Therapy |
| Placebo--equivalent to breathing air | Sham comparator | Not described Receives: Procedure: Hyperbaric Oxygen Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on symptom assessment battery
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
Measured: 2-4 weeks before treatment
Improvement on symptom assessment battery
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
Measured: 24-72 hours after final treatment
Improvement on symptom assessment battery
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
Measured: 3 months after final treatment.
Secondary outcomes (9)
Neuropsychological Testing Battery
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
Measured: 2-4 weeks before treatment
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging and Eye tracking
Measured: 24-72 hours after final treatment
Common Military Task Tests
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
Measured: 2-4 weeks before treatment
Neuropsychological Testing Battery
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
Measured: 24-72 hours after final treatment
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking
Measured: 3 months after final treatment.
Neuropsychological Testing Battery
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
Measured: 3 months after final treatment.
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking
Measured: 2-4 weeks before treatment
Common Military Task Tests
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
Measured: 24-72 hours after final treatment
Common Military Task Tests
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
Measured: 3 months after final treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Naval Medical Center, Portsmouth, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Responsible party
- Sponsor
- Investigators
- David X Cifu, MD, Principal investigator, Virginia Commonwealth UniversityBrett Hart, MD, Principal investigator, Naval Operational Medicine InstituteMichelle Nichols, MSN, RN, Principal investigator, McGuire Veterans' Affairs Medical CenterJustin O Alicea, Study director, Virginia Commonwealth UniversitySteven L West, PhD, Study director, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220713
- Sponsor's protocol ID
- N66001-09-2-2060
- Other IDs
- 01609, NOMI.2010.002, HM12204
- Acronym
- HBOT
- Status last verified
- Aug 2013
- First submitted
- 6 Oct 2010
- Last updated
- 27 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01220713
- Acronym / sponsor ID
- HBOT / N66001-09-2-2060
- Keywords
- Traumatic Brain Injury, Veterans, Hyperbaric Oxygen Treatment, OEF/OIF, Post-Concussive Symptoms, Blast Exposure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- United States Naval Medical Center, Portsmouth, Hunter Holmes Mcguire Veteran Affairs Medical Center
- Study start
- Jun 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment 1--1.5 atm abs | Experimental | Procedure: Hyperbaric Oxygen Therapy |
| Treatment 2--2.0 atm abs | Experimental | Procedure: Hyperbaric Oxygen Therapy |
| Placebo--equivalent to breathing air | Sham comparator | Procedure: Hyperbaric Oxygen Therapy |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Post-Deployment status after having served in OIF/OEF
- 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]
- Diagnosis of MTBI within 3 years as confirmed by the TBI specialty team at the Richmond VAMC
- Presence of post-concussive symptoms from MTBI, confirmed by the VCU-CERSE team at the Richmond VAMC, for at least 3 months
- Medical clearance to undergo hyperbaric oxygen treatment
Key exclusion criteria (12 listed)
- Traumatic Brain Injury with a primary etiology other than blast
- 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.)
- Past history of moderate or severe TBI
- Active diagnosis of Post-traumatic Stress Disorder
- Active diagnosis of Generalized Anxiety Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen Therapy1.5 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. | Procedure or surgery | Treatment 1--1.5 atm abs |
| Hyperbaric Oxygen Therapy2.0 atm abs oxygen equivalent of 100% oxygen (no nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks. | Procedure or surgery | Treatment 2--2.0 atm abs |
| Hyperbaric Oxygen Therapysham--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. | Procedure or surgery | Placebo--equivalent to breathing air |
Primary outcome
Improvement on symptom assessment battery
Time frame: 2-4 weeks before treatment
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
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.
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
9 secondary outcomes
Neuropsychological Testing Battery
Time frame: 2-4 weeks before treatment
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging and Eye tracking
Time frame: 24-72 hours after final treatment
Common Military Task Tests
Time frame: 2-4 weeks before treatment
Neuropsychological Testing Battery
Time frame: 24-72 hours after final treatment
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking
Time frame: 3 months after final treatment.
Neuropsychological Testing Battery
Time frame: 3 months after final treatment.
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking
Time frame: 2-4 weeks before treatment
Common Military Task Tests
Time frame: 24-72 hours after final treatment
Common Military Task Tests
Time frame: 3 months after final treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David X Cifu, MD principal investigator
Virginia Commonwealth University
Brett Hart, MD principal investigator
Naval Operational Medicine Institute
Michelle Nichols, MSN, RN principal investigator
McGuire Veterans' Affairs Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hyperbaric Oxygen Therapy in people with Mild Traumatic Brain Injury and Post-Concussive Syndrome, run by Virginia Commonwealth University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement on symptom assessment battery (time frame: 2-4 weeks before treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2013.