Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH-10-1-0962 | Other Identifier | USAMRMC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| U.S. Army Medical Research and Development Command | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyperbaric Oxygen | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Working Memory | One week after final HBOT | |
| Neurobehavioral Symptom Inventory (NSI) | One week after final HBOT |
| Measure | Description | Time Frame |
|---|---|---|
| Wechsler Abbreviated Scale of Intelligence II (WASI-II) | 2 months after final HBOT | |
| Wechsler Memory Scale-IV (WMS-IV | 2 months after final HBOT | |
| Rey Auditory Verbal Learning Test (RAVLT) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cara J Rowe, MSW | Contact | 504-427-5632 | cjoh26@lsuhsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul G Harch, MD | Louisiana State University Health Sciences Center in New Orleans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louisiana State University Health Sciences Center-New Orleans | Recruiting | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32189664 | Derived | 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. |
Not provided
Not provided
Not provided
Randomized prospective controlled
Not provided
Not provided
Neuropsychological testers and neuropsychologist blinded to treatment group.
|
|
| No Hyperbaric Oxygen | Drug | 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. |
|
|
| 2 months after final HBOT |
| Benton Visual Retention Test with Alternate Forms (Benton VRT) | 2 months after final HBOT |
| Stroop Color-Word Interference Test | 2 months after final HBOT |
| Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS) | 2 months after final HBOT |
| Category Fluency Test (Animal) | 2 months after final HBOT |
| Automated Neuropsychological Assessment Metrics-4 (ANAM-4) | 2 months after final HBOT |
| Pittsburgh Sleep Quality Index (PSQI) | 2 months after final HBOT |
| Quality of Life After Brain Injury (QOLIBRI) | 2 months after final HBOT |
| ID | Term |
|---|---|
| D038223 | Post-Concussion Syndrome |
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D016489 | Head Injuries, Closed |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
Not provided
Not provided