Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

Louisiana State University

Status and phase: Unknown; Phase 3

Conditions: Traumatic Brain Injury; Post-Concussion Syndrome

Treatments: Drug: Hyperbaric Oxygen; Drug: No Hyperbaric Oxygen

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02089594

LSU IRB #7381

W81XWH-10-1-0962 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 59 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults, 18-65 years old.
2. One or more mild TBI's due to blunt or blast injury.
3. Meets criteria for PPCS.
4. Ability to complete the NSI.
5. Ability to complete the PCL-M or C.
6. Ability to complete CAPS if needed.
7. Absence of acute cardiac arrest or hemorrhagic shock at time of TBI that would cause a global ischemic insult to the TBI.
8. Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug Abuse Screening Test (DAST).
9. Ability to complete a urine toxicology screen for drugs of abuse.
10. Negative pregnancy test in females. Female subjects will need to have a negative urinalysis result in order to start or continue treatment.
11. Subjects must be legally responsible, speak and understand English fluently, and be able to sign their own consent documents.
12. Otherwise good health.

Exclusion criteria

1. Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication, bullous emphysema).
2. 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).
3. Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation for MRI).
4. Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerative diseases, multiple sclerosis, congenital neurological disorder.
5. Participation in another experimental trial with active intervention.
6. High probability of inability to complete the experimental protocol (e.g. terminal condition or inability to complete outcome instruments).
7. Previous HBOT.
8. History of hospitalization for past stroke, non-febrile seizures, or any seizure history other than seizure at the time of TBI.
9. Past or current history of mental retardation.
10. Pre-/post-TBI history of systemic illness with impact on central nervous system (P.I.'s decision).
11. 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.
12. Any concurrent systemic illness whose symptomatology confounds the diagnosis of PPCS (P.I.'s decision).
13. Active malignancy undergoing treatment.
14. Taking lithium.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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59 participants in 2 patient groups

Hyperbaric Oxygen Therapy (HBOT)

Experimental group

Description:

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.

Treatment:

Drug: Hyperbaric Oxygen

No Hyperbaric Oxygen Treatment (HBOT)

Experimental group

Description:

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.

Treatment:

Drug: No Hyperbaric Oxygen

Drug: Hyperbaric Oxygen