Post-concussive SymptomsPhase 2HOPPSNCT01306968
Hyperbaric Oxygen Therapy (HBO2) for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (mTBI)
A Phase 2 study testing hyperbaric oxygen in people with Post-concussive Symptoms and Traumatic Brain Injury, run by U.S. Army Medical Research and Development Command at 5 sites in United States.
Trial summary
This is a Phase II randomized trial designed to describe the magnitude of change between baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests administered at time points corresponding before and after 10 weeks over observation in four groups: A military population with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-concussive Symptoms, Traumatic Brain Injury
- What is being tested?
- hyperbaric oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 5 sitesUnited States
- Study dates
- Feb 2011to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers must have history of at least one mild traumatic brain injury (mTBI) with persistent symptoms that meets all the following criteria:
- Brain injury that occurred more than 4 months prior to enrollment, with the most recent injury occurring no earlier than October 7, 2001.
- Most recent traumatic brain injury occurred while serving on active duty, and while deployed to the United States (US) Central Command (USCENTCOM).
- Most recent traumatic brain injury was caused by blast exposure or blunt trauma.
- Most recent traumatic brain injury resulted in at least one of the following: a period of loss of or a decreased level of consciousness (up to 30 minutes); a loss of memory for events immediately before or after the injury (up to 24 hours); or alteration in mental state at the time of the injury (becoming dazed or confused).
- Volunteers must also meet all the following criteria:
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- 18-65 years old at the time of study enrollment.
- A TRICARE beneficiary at the time of consent and during study participation.
- Has current complaints of brain injury symptoms such as headache, dizziness, or cognitive or affective problems that score at least 3 post-concussive symptoms as assessed by the Ohio State University (OSU) Traumatic Brain Injury (TBI) Identification (ID) Method interview
- Has received current local care pharmacologic and non-pharmacologic interventions for TBI and any concomitant posttraumatic stress disorder (PTSD) with no significant change in therapy for at least 1 month
- Willing and committed to comply with the research protocol and complete all outcome measures.
- Able to self-consent.
- Able to speak and read English, as primary language.
- Able to participate in all outcome measures.
- Able to equalize middle ear pressure.
Who cannot join
- History of brain injury of moderate or severe degree: duration of loss of consciousness at the time of injury greater than 30 minutes, or duration of post-traumatic amnesia greater than 24 hours, or brain injury of a penetrating etiology.
- History of brain injury not of traumatic etiology, such as stroke or drug-induced coma.
- Prior treatment with HBO2.
- Hyperbaric chamber inside attendant, professional (paid)underwater diver (commercial, operational/ military, instructor), or technical diver.
- Pregnancy, women who plan to become pregnant during the study period, women who do not agree to practice an acceptable form of birth control during the study period, or women who are breastfeeding;
- Those who are unable to participate fully in outcome assessments (Blind in one or both eyes; Deaf in one or both ears; or Ambulation with assistive devices
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- Pre-existing diagnosis of a psychotic disorder(s): schizophrenia, dissociative disorder, and bipolar disease.
- Verifiable degenerative mental disease (e.g., Alzheimer's disease, multiple sclerosis, senile dementia).
- Epilepsy or seizure disorder requiring anticonvulsants.
- Active malignancy, prior malignancy (except basal cell carcinoma) within the last 5 years.
- Presence of chronic debilitating disease (e.g., end-stage renal disease, end-stage liver disease, all types of diabetes with or without sequelae).
- Documented clinically significant uncorrected anemia
- Documented sickle cell disease.
- History of therapeutic ionizing radiation to the head.
- Verifiable diagnosis of learning disability.
- Positive urine test for an illicit substance(s).
- Any condition or use of prescribed medication (lithium, cisplatin, doxorubicin, or bleomycin) in which receipt of HBO2 would impact the safety of the individual.
- Anticipated administrative separation, prolonged temporary assigned duty (TAD/TDY) or deployment within 3 months after randomization
- Claustrophobia (unwilling or unable to enter hyperbaric chamber).
- Inability to protect airway or requires frequent suctioning; presence of tracheostomy
- Heart failure with ejection fraction < 50% (due to increased risk for precipitating acute lung edema during exposure to HBO2).
- Emphysema, chronic bronchitis, or bullous lung disease (due to risk for pulmonary barotrauma during hyperbaric decompression).
- Diabetes (relative contraindication related to risk of hypoglycemia).
- Presence of implanted device (e.g., cardiac defibrillator, intrathecal drug delivery device, cochlear implant) that poses increased risk to subject during hyperbaric exposure.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Naval Hospital Camp Pendleton
Camp Pendleton, California, 92055
Evans Army community Hospital Fort Carson
Fort Carson, Colorado, 80913
Eisenhower Army Medical Center
Fort Gordon, Georgia, 30905
Naval Hospital Camp Lejeune
Marine Corps Base Camp Lejeune, North Carolina, 28547
Study Coordinating Center, LDS Hospital
Salt Lake City, Utah, 84143
About this study
Official title: A Pilot Phase II Study of Hyperbaric Oxygen for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (HOPPS)
This is a Phase II randomized trial designed to describe the magnitude of change between baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests administered at time points corresponding before and after 10 weeks over observation in four groups:
- A military population with post-concussion syndrome (mTBI) receiving local standard care
- A military population with post-concussion syndrome (mTBI) receiving local standard care and sham hyperbaric oxygen sessions
- A military population with post-concussion syndrome (mTBI) receiving local standard care and hyperbaric oxygen at 1.5 atmospheres sessions
- A otherwise similar group with PTSD but no history of TBI receiving local standard care Differences and variability of the tests will be used for determining the optimum primary endpoint(s) for future trial, as well as for refinement of sample size and power calculations for these studies. The groups undergoing hyperbaric sessions will be assigned to receive HBO2 or sham using a randomized, double blind design.
Read more
Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in the United States and who will remain in the military for the entire study period, aged 18-65 years who have been deployed one or more times to the US Central Command since the initiation of Operation Enduring Freedom (October 7, 2001) who either:
- have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR
- have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4 months) symptoms sustained during one or more of those deployments
Read the detailed description
Brain injury due to trauma is very common; nonetheless, no pharmacological therapy is known to improve outcomes. Medications are used to treat symptoms, such as seizures and affective disorders, but are not intended to affect the fundamental problem. If HBO2, which is regularly available and relatively safe, improves outcome in brain-injured subjects by treating the underlying pathophysiology of post-concussive syndrome, this would represent a significant advance in treatment of brain injury. Hyperbaric oxygen (HBO2) has been proposed as a treatment for patients with TBI.
Hyperbaric oxygen is one of the first pharmacologic interventions being tested in this population of individuals with mild TBI and chronic post-concussive symptoms targeted to improve cognition, memory, and functional status. However, much is unknown about how to measure improvement in post-concussive symptoms after an intervention in the targeted active duty population. In preparation for a pivotal efficacy study, the objectives of this study are to characterize two candidate primary outcome tools in our intended study population, the RPQ and the NSI, in order to better estimate the sample size needed to answer the efficacy question.
Agency for Healthcare Research and Quality (AHRQ) conducted a comprehensive review of the literature, interviewed subject matter experts (SME), and conducted focus groups with SMEs to evaluate the evidence for HBO2 for patients with TBI. The AHRQ concluded that "Although they are cited frequently, the case series and time-series studies of HBO2 for TBI patients had serious flaws. There were no high-quality studies of the use of HBO2 to improve function and quality of life in patients with chronic, stable disabilities from TBI. The most important gap in the evidence is a lack of a good quality time-series study or controlled trial of the effects of HBO2 on cognition, memory, and functional status in patients with deficits due to mild chronic TBI." Similarly, the Department of Health and Human Services (DHHS) has not approved HBO2 therapy for the treatment of TBI as a covered condition, citing the lack of supporting evidence for clinical efficacy.
The Defense Centers of Excellence for Psychological Health and Traumatic concluded that sufficient case reports, early safety and feasibility study data, and basic scientific plausibility exist to warrant prompt experimental study of HBO2 in the care of the full spectrum of chronic TBI. This would best be accomplished in a randomized, double-blind, multi-center clinical trial.
This Phase 2 study, through specific study design, inclusion and exclusion criteria, interim and end point analyses, treatment protocols, dose-response and safety issues, evaluation methodologies, safety, and outcome measures address the need for clinical efficacy.
In preparation for the pivotal trial, the purpose of this Phase II study is to describe the magnitude of change between baseline and follow-up outcomes for a battery of neuropsychological tests within groups. A secondary objective is to explore changes across the four groups. Differences and variability of the tests will be used for determining the optimum primary endpoint(s) for the Phase III trial, as well as for refinement of sample size and power calculations for this future study. Recruitment, randomization, blinding, and study and intervention logistics and planning will also be assessed.
- Conditions
- Post-concussive Symptoms, Traumatic Brain Injury
- Being tested
- hyperbaric oxygen, sham hyperbaric air
- Keywords
- mild tramatic brain injury, mTBI, hyperbaric oxygen, post concussive symptoms, active duty military, veterans
- Medical subject headings
- 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 oxygenDrug
Also called medical 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).
sham hyperbaric airOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard TBI Care | No intervention | Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) |
| HBO2 Group | Experimental | 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 Receives: Drug: hyperbaric oxygen |
| Sham Group | Sham comparator | Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA) Receives: Other: sham hyperbaric air |
| PTSD With no History of TBI | No intervention | Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group does not receive HBO2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat
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.
Measured: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat
Means for the change from baseline to follow-up visit 2
Measured: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population
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.
Measured: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population
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.
Measured: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-concussive SymptomsStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Scott Miller, MD, COL, Principal investigator, United States Army Medical Materiel Development Activity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306968
- Sponsor's protocol ID
- S-10-09
- Acronym
- HOPPS
- Status last verified
- Aug 2014
- First submitted
- 24 Feb 2011
- Last updated
- 5 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Weaver LK, Churchill S, Wilson SH, Hebert D, Deru K, Lindblad AS. A composite outcome for mild traumatic brain injury in trials of hyperbaric oxygen. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):341-352.
PubMed 31394603Churchill S, Deru K, Weaver LK, Wilson SH, Hebert D, Miller RS, Lindblad AS. Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):331-340.
PubMed 31394602Miller RS, Weaver LK, Bahraini N, Churchill S, Price RC, Skiba V, Caviness J, Mooney S, Hetzell B, Liu J, Deru K, Ricciardi R, Fracisco S, Close NC, Surrett GW, Bartos C, Ryan M, Brenner LA; HOPPS Trial Team. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial. JAMA Intern Med. 2015 Jan;175(1):43-52. doi: 10.1001/jamainternmed.2014.5479.
PubMed 25401463
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Study of Hyperbaric Oxygen for Persistent Post-concussive Symptoms After Mild Traumatic Brain Injury (HOPPS)
- ClinicalTrials.gov ID
- NCT01306968
- Acronym / sponsor ID
- HOPPS / S-10-09
- Conditions
- Post-concussive Symptoms, Traumatic Brain Injury
- Keywords
- mild tramatic brain injury, mTBI, hyperbaric oxygen, post concussive symptoms, active duty military, veterans
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Posted 5 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II randomized trial designed to describe the magnitude of change between baseline and follow-up outcomes for symptom surveys and a battery of neuropsychological tests administered at time points corresponding before and after 10 weeks over observation in four groups:
- A military population with post-concussion syndrome (mTBI) receiving local standard care
- A military population with post-concussion syndrome (mTBI) receiving local standard care and sham hyperbaric oxygen sessions
- A military population with post-concussion syndrome (mTBI) receiving local standard care and hyperbaric oxygen at 1.5 atmospheres sessions
- A otherwise similar group with PTSD but no history of TBI receiving local standard care Differences and variability of the tests will be used for determining the optimum primary endpoint(s) for future trial, as well as for refinement of sample size and power calculations for these studies. The groups undergoing hyperbaric sessions will be assigned to receive HBO2 or sham using a randomized, double blind design.
Active duty military (Army, Marine, Navy, Air Force) men and non-pregnant women residing in the United States and who will remain in the military for the entire study period, aged 18-65 years who have been deployed one or more times to the US Central Command since the initiation of Operation Enduring Freedom (October 7, 2001) who either:
- have been diagnosed with Post Traumatic Stress Disorder (PTSD) as a result of traumatic events that occurred during the qualifying CENTCOM deployment, but have no diagnosed or suspected lifetime brain injuries resulting in loss or alteration of consciousness; OR
- have been diagnosed with at least one mild brain injury (mTBI) with persistent (> 4 months) symptoms sustained during one or more of those deployments
Detailed description
Brain injury due to trauma is very common; nonetheless, no pharmacological therapy is known to improve outcomes. Medications are used to treat symptoms, such as seizures and affective disorders, but are not intended to affect the fundamental problem. If HBO2, which is regularly available and relatively safe, improves outcome in brain-injured subjects by treating the underlying pathophysiology of post-concussive syndrome, this would represent a significant advance in treatment of brain injury. Hyperbaric oxygen (HBO2) has been proposed as a treatment for patients with TBI.
Hyperbaric oxygen is one of the first pharmacologic interventions being tested in this population of individuals with mild TBI and chronic post-concussive symptoms targeted to improve cognition, memory, and functional status. However, much is unknown about how to measure improvement in post-concussive symptoms after an intervention in the targeted active duty population. In preparation for a pivotal efficacy study, the objectives of this study are to characterize two candidate primary outcome tools in our intended study population, the RPQ and the NSI, in order to better estimate the sample size needed to answer the efficacy question.
Agency for Healthcare Research and Quality (AHRQ) conducted a comprehensive review of the literature, interviewed subject matter experts (SME), and conducted focus groups with SMEs to evaluate the evidence for HBO2 for patients with TBI. The AHRQ concluded that "Although they are cited frequently, the case series and time-series studies of HBO2 for TBI patients had serious flaws. There were no high-quality studies of the use of HBO2 to improve function and quality of life in patients with chronic, stable disabilities from TBI. The most important gap in the evidence is a lack of a good quality time-series study or controlled trial of the effects of HBO2 on cognition, memory, and functional status in patients with deficits due to mild chronic TBI." Similarly, the Department of Health and Human Services (DHHS) has not approved HBO2 therapy for the treatment of TBI as a covered condition, citing the lack of supporting evidence for clinical efficacy.
The Defense Centers of Excellence for Psychological Health and Traumatic concluded that sufficient case reports, early safety and feasibility study data, and basic scientific plausibility exist to warrant prompt experimental study of HBO2 in the care of the full spectrum of chronic TBI. This would best be accomplished in a randomized, double-blind, multi-center clinical trial.
This Phase 2 study, through specific study design, inclusion and exclusion criteria, interim and end point analyses, treatment protocols, dose-response and safety issues, evaluation methodologies, safety, and outcome measures address the need for clinical efficacy.
In preparation for the pivotal trial, the purpose of this Phase II study is to describe the magnitude of change between baseline and follow-up outcomes for a battery of neuropsychological tests within groups. A secondary objective is to explore changes across the four groups. Differences and variability of the tests will be used for determining the optimum primary endpoint(s) for the Phase III trial, as well as for refinement of sample size and power calculations for this future study. Recruitment, randomization, blinding, and study and intervention logistics and planning will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard TBI Care | No intervention | –Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) |
| HBO2 Group | Experimental | Drug: hyperbaric oxygenRoutine 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 |
| Sham Group | Sham comparator | Other: sham hyperbaric airRoutine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA) |
| PTSD With no History of TBI | No intervention | –Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group does not receive HBO2. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Volunteers must have history of at least one mild traumatic brain injury (mTBI) with persistent symptoms that meets all the following criteria:
- Volunteers must also meet all the following criteria:
Key exclusion criteria (24 listed)
- History of brain injury of moderate or severe degree: duration of loss of consciousness at the time of injury greater than 30 minutes, or duration of post-traumatic amnesia greater than 24 hours, or brain injury of a penetrating etiology.
- History of brain injury not of traumatic etiology, such as stroke or drug-induced coma.
- Prior treatment with HBO2.
- Hyperbaric chamber inside attendant, professional (paid)underwater diver (commercial, operational/ military, instructor), or technical diver.
- Pregnancy, women who plan to become pregnant during the study period, women who do not agree to practice an acceptable form of birth control during the study period, or women who are breastfeeding;
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 oxygenAlso: medical oxygenThe 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). | Drug | HBO2 Group |
| sham hyperbaric airA 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. | Other | Sham Group |
Primary outcome
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat
Time frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
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.
Change in Post-concussion Symptom Scores Using RPQ - Intent to Treat
Time frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
Means for the change from baseline to follow-up visit 2
Post-Intervation Post-concussion Symptom Scores Using RPQ - Per Protocol Population
Time frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
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.
Change in Post-concussion Symptom Scores Using RPQ - Per Protocol Population
Time frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31394603Weaver LK, Churchill S, Wilson SH, Hebert D, Deru K, Lindblad AS. A composite outcome for mild traumatic brain injury in trials of hyperbaric oxygen. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):341-352.
- Derived from this study: PubMed 31394602Churchill S, Deru K, Weaver LK, Wilson SH, Hebert D, Miller RS, Lindblad AS. Adverse events and blinding in two randomized trials of hyperbaric oxygen for persistent post-concussive symptoms. Undersea Hyperb Med. 2019 BIMA Special Edition No. Feb;46(3):331-340.
- Derived from this study: PubMed 25401463Miller RS, Weaver LK, Bahraini N, Churchill S, Price RC, Skiba V, Caviness J, Mooney S, Hetzell B, Liu J, Deru K, Ricciardi R, Fracisco S, Close NC, Surrett GW, Bartos C, Ryan M, Brenner LA; HOPPS Trial Team. Effects of hyperbaric oxygen on symptoms and quality of life among service members with persistent postconcussion symptoms: a randomized clinical trial. JAMA Intern Med. 2015 Jan;175(1):43-52. doi: 10.1001/jamainternmed.2014.5479.
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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.
Scott Miller, MD, COL principal investigator
United States Army Medical Materiel Development Activity
5 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 in people with Post-concussive Symptoms and Traumatic Brain Injury, run by U.S. Army Medical Research and Development Command at 5 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 15 inclusion and 24 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-Intervation Post-concussion Symptom Scores Using RPQ - Intent to Treat (time frame: Follow-up Visit 2; Day 56 (up to day 100) for groups not recieving HBO2, Day 70 for groups recieving HBO2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01306968, which also lists 3 linked publications.
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 5 Sep 2014.