Post-Concussion SyndromePhase 3NCT02089594
Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)
A Phase 3 study testing Hyperbaric Oxygen and No Hyperbaric Oxygen in people with Post-Concussion Syndrome and Traumatic Brain Injury, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-Concussion Syndrome, Traumatic Brain Injury
- What is being tested?
- Hyperbaric Oxygen and No Hyperbaric Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Mar 2019
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, 18-65 years old.
- One or more mild TBI's due to blunt or blast injury.
- Meets criteria for PPCS.
- Ability to complete the NSI.
- Ability to complete the PCL-M or C.
- Ability to complete CAPS if needed.
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- Absence of acute cardiac arrest or hemorrhagic shock at time of TBI that would cause a global ischemic insult to the TBI.
- Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug Abuse Screening Test (DAST).
- Ability to complete a urine toxicology screen for drugs of abuse.
- Negative pregnancy test in females. Female subjects will need to have a negative urinalysis result in order to start or continue treatment.
- Subjects must be legally responsible, speak and understand English fluently, and be able to sign their own consent documents.
- Otherwise good health.
Who cannot join
- Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication, bullous emphysema).
- Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
- Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation for MRI).
- Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerative diseases, multiple sclerosis, congenital neurological disorder.
- Participation in another experimental trial with active intervention.
- High probability of inability to complete the experimental protocol (e.g. terminal condition or inability to complete outcome instruments).
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- Previous HBOT.
- History of hospitalization for past stroke, non-febrile seizures, or any seizure history other than seizure at the time of TBI.
- Past or current history of mental retardation.
- Pre-/post-TBI history of systemic illness with impact on central nervous system (P.I.'s decision).
- Pre-injury psychiatric disorders for which the patient was on medication at the time of the brain injury responsible for the patient's diagnosis of TBI/PPCS.
- Any concurrent systemic illness whose symptomatology confounds the diagnosis of PPCS (P.I.'s decision).
- Active malignancy undergoing treatment.
- Taking lithium.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Louisiana State University Health Sciences Center-New Orleans
New Orleans, Louisiana, 70112
Paul G Harch, MD
Susan Andrews, PhD
About this study
Official title: Hyperbaric Oxygen Therapy Treatment of Chronic Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)
Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).
Read the detailed description
This is a randomized prospective controlled single-blind crossover clinical trial of 1.5 ATA (atmospheres absolute) HBOT versus maintenance medication and counseling. One hundred adult subjects (50 at Louisiana State University Health Sciences Center-New Orleans and 50 at Oklahoma State University School of Medicine) with mTBI/PPCS who have been symptomatic continuously for at least six months from one or more mild traumatic brain injuries will be enrolled and randomized to either 40 HBOTs or no treatment. After the 8-week treatment period the no treatment group will be crossed over to receive 40 HBOTs.
- Conditions
- Post-Concussion Syndrome, Traumatic Brain Injury
- Being tested
- Hyperbaric Oxygen, No Hyperbaric Oxygen
- Keywords
- Hyperbaric Oxygen Treatment, Mild Traumatic Brain Injury, Persistent Post-Concussion Syndrome
- Medical subject headings
- Post-Concussion Syndrome, Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric OxygenDrug
Also called Hyperbaric Oxygen Therapy
HBOT Group: Pressurization will proceed with 100% oxygen at 1.0 pounds per square inch (psi) per minute, the minimal pressurization rate, to 1.5 ATA (atmospheres absolute) or 7.35 psi and will take approximately 7 minutes. Pressurization will then resume until the final depth of 1.5 ATA is achieved. The patient will remain at depth for approximately 45 minutes and the subject will be informed of the onset of depressurization, which will occur at the same rate as pressurization. Total dive time will be 60 minutes.
No Hyperbaric OxygenDrug
Also called Hyperbaric Oxygen Therapy
Subjects will receive their usual care during the equivalent eight-week HBOT treatment period. There will be no hyperbaric chamber experience. At the conclusion of the eight-week control period both control and experimental subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group.
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric Oxygen Therapy (HBOT) | Experimental | Hyperbaric Oxygen Therapy at 1.5 ATA (atmospheres absolute). The subjects will receive 40 low pressure HBOT's on a once/day, 5d/week eight week schedule. Receives: Drug: Hyperbaric Oxygen |
| No Hyperbaric Oxygen Treatment (HBOT) | Experimental | Subjects will receive eight weeks of no hyperbaric treatment while they continue any pre-study maintenance medication and/or pre-study counseling. Subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group. Receives: Drug: Hyperbaric Oxygen; Drug: No Hyperbaric Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working Memory
Measured: One week after final HBOT
Neurobehavioral Symptom Inventory (NSI)
Measured: One week after final HBOT
Secondary outcomes (10)
Wechsler Abbreviated Scale of Intelligence II (WASI-II)
Measured: 2 months after final HBOT
Wechsler Memory Scale-IV (WMS-IV
Measured: 2 months after final HBOT
Rey Auditory Verbal Learning Test (RAVLT)
Measured: 2 months after final HBOT
Benton Visual Retention Test with Alternate Forms (Benton VRT)
Measured: 2 months after final HBOT
Stroop Color-Word Interference Test
Measured: 2 months after final HBOT
Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS)
Measured: 2 months after final HBOT
Category Fluency Test (Animal)
Measured: 2 months after final HBOT
Automated Neuropsychological Assessment Metrics-4 (ANAM-4)
Measured: 2 months after final HBOT
Pittsburgh Sleep Quality Index (PSQI)
Measured: 2 months after final HBOT
Quality of Life After Brain Injury (QOLIBRI)
Measured: 2 months after final HBOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Concussion SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized prospective controlled
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Paul G Harch, MD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089594
- Sponsor's protocol ID
- LSU IRB #7381
- Other IDs
- W81XWH-10-1-0962
- Status last verified
- Apr 2017
- First submitted
- 14 Mar 2014
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Harch PG, Andrews SR, Rowe CJ, Lischka JR, Townsend MH, Yu Q, Mercante DE. Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial. Med Gas Res. 2020 Jan-Mar;10(1):8-20. doi: 10.4103/2045-9912.279978.
PubMed 32189664
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Therapy Treatment of Chronic Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)
- ClinicalTrials.gov ID
- NCT02089594
- Acronym / sponsor ID
- LSU IRB #7381
- Conditions
- Post-Concussion Syndrome, Traumatic Brain Injury
- Keywords
- Hyperbaric Oxygen Treatment, Mild Traumatic Brain Injury, Persistent Post-Concussion Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- May 2014
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 18 Mar 2014 (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.
Objective/Hypothesis: An eight-week course of forty low-pressure Hyperbaric Oxygen Treatment's (HBOT's) can significantly improve symptoms and cognitive function in subjects with the persistent-post concussion syndrome (PPCS) of mild traumatic brain injury (mTBI).
Detailed description
This is a randomized prospective controlled single-blind crossover clinical trial of 1.5 ATA (atmospheres absolute) HBOT versus maintenance medication and counseling. One hundred adult subjects (50 at Louisiana State University Health Sciences Center-New Orleans and 50 at Oklahoma State University School of Medicine) with mTBI/PPCS who have been symptomatic continuously for at least six months from one or more mild traumatic brain injuries will be enrolled and randomized to either 40 HBOTs or no treatment. After the 8-week treatment period the no treatment group will be crossed over to receive 40 HBOTs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized prospective controlled
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric Oxygen Therapy (HBOT) | Experimental | Drug: Hyperbaric OxygenHyperbaric Oxygen Therapy at 1.5 ATA (atmospheres absolute). The subjects will receive 40 low pressure HBOT's on a once/day, 5d/week eight week schedule. |
| No Hyperbaric Oxygen Treatment (HBOT) | Experimental | Drug: Hyperbaric Oxygen, Drug: No Hyperbaric OxygenSubjects will receive eight weeks of no hyperbaric treatment while they continue any pre-study maintenance medication and/or pre-study counseling. Subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adults, 18-65 years old.
- One or more mild TBI's due to blunt or blast injury.
- Meets criteria for PPCS.
- Ability to complete the NSI.
- Ability to complete the PCL-M or C.
Key exclusion criteria (14 listed)
- Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication, bullous emphysema).
- Unstable medical conditions that are contraindicated in HBOT (e.g. severe congestive heart failure or heart failure requiring hospital emergency evaluation or admission in the previous year).
- Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation for MRI).
- Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerative diseases, multiple sclerosis, congenital neurological disorder.
- Participation in another experimental trial with active intervention.
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: Hyperbaric Oxygen TherapyHBOT Group: Pressurization will proceed with 100% oxygen at 1.0 pounds per square inch (psi) per minute, the minimal pressurization rate, to 1.5 ATA (atmospheres absolute) or 7.35 psi and will take approximately 7 minutes. Pressurization will then resume until the final depth of 1.5 ATA is achieved. The patient will remain at depth for approximately 45 minutes and the subject will be informed of the onset of depressurization, which will occur at the same rate as pressurization. Total dive time will be 60 minutes. | Drug | Hyperbaric Oxygen Therapy (HBOT), No Hyperbaric Oxygen Treatment (HBOT) |
| No Hyperbaric OxygenAlso: Hyperbaric Oxygen TherapySubjects will receive their usual care during the equivalent eight-week HBOT treatment period. There will be no hyperbaric chamber experience. At the conclusion of the eight-week control period both control and experimental subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group. | Drug | No Hyperbaric Oxygen Treatment (HBOT) |
Primary outcome
Working Memory
Time frame: One week after final HBOT
Neurobehavioral Symptom Inventory (NSI)
Time frame: One week after final HBOT
10 secondary outcomes
Wechsler Abbreviated Scale of Intelligence II (WASI-II)
Time frame: 2 months after final HBOT
Wechsler Memory Scale-IV (WMS-IV
Time frame: 2 months after final HBOT
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: 2 months after final HBOT
Benton Visual Retention Test with Alternate Forms (Benton VRT)
Time frame: 2 months after final HBOT
Stroop Color-Word Interference Test
Time frame: 2 months after final HBOT
Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS)
Time frame: 2 months after final HBOT
Category Fluency Test (Animal)
Time frame: 2 months after final HBOT
Automated Neuropsychological Assessment Metrics-4 (ANAM-4)
Time frame: 2 months after final HBOT
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 months after final HBOT
Quality of Life After Brain Injury (QOLIBRI)
Time frame: 2 months after final HBOT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Derived from this study: PubMed 32189664Harch PG, Andrews SR, Rowe CJ, Lischka JR, Townsend MH, Yu Q, Mercante DE. Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial. Med Gas Res. 2020 Jan-Mar;10(1):8-20. doi: 10.4103/2045-9912.279978.
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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.
Paul G Harch, MD principal investigator
Louisiana State University Health Sciences Center in New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyperbaric Oxygen and No Hyperbaric Oxygen in people with Post-Concussion Syndrome and Traumatic Brain Injury, run by Louisiana State University Health Sciences Center in New Orleans at 1 site 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 12 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cara J Rowe, MSW (504-427-5632, cjoh26@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working Memory (time frame: One week after final HBOT). The study lists 2 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 NCT02089594, which also lists 1 linked publication.
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 18 Apr 2017.