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

NCT ID: NCT02089594

Last Updated: 2017-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-03-31

Brief 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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hyperbaric Oxygen Therapy (HBOT)

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.

Group Type: EXPERIMENTAL

Hyperbaric Oxygen

Intervention Type: 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.

No Hyperbaric Oxygen Treatment (HBOT)

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.

Group Type: EXPERIMENTAL

Hyperbaric Oxygen

Intervention Type: 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.

No Hyperbaric Oxygen

Intervention Type: 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.

Interventions

Hyperbaric Oxygen

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.

Intervention Type: DRUG

No Hyperbaric Oxygen

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.

Intervention Type: DRUG

Other Intervention Names

Hyperbaric Oxygen Therapy; Hyperbaric Oxygen Therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: lead

Responsible Party

Paul G. Harch, M.D.

Clinical Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul G Harch, MD

Role: PRINCIPAL_INVESTIGATOR

Louisiana State University Health Sciences Center in New Orleans

Locations

Louisiana State University Health Sciences Center-New Orleans

New Orleans, Louisiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cara J Rowe, MSW

Role: CONTACT

cjoh26@lsuhsc.edu

504-427-5632

References

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.

Reference Type: DERIVED

PMID: 32189664 (View on PubMed)

Other Identifiers

W81XWH-10-1-0962

Identifier Type: OTHER

Identifier Source: secondary_id

LSU IRB #7381

Identifier Type: -

Identifier Source: org_study_id