Recruiting
Phase 3

Hyperbaric Oxygen Treatment

Sponsor:

Louisiana State University Health Sciences Center in New Orleans

Code:

NCT02089594

Conditions

Post-Concussion Syndrome

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Hyperbaric Oxygen

No Hyperbaric Oxygen

Study Details

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).

Conditions

Post-Concussion Syndrome

Traumatic Brain Injury

Study ID

NCT02089594

Start date

May, 2014

Status verified date

Apr, 2017

Completion date

Mar, 2019

Anticipated

Primary completion date

Mar, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

59 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

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.

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.

Primary outcome measure

  • Working Memory [ Time Frame: One week after final HBOT ]
  • Neurobehavioral Symptom Inventory (NSI) [ Time Frame: One week after final HBOT ]

Central Contacts and Locations

Central contacts

Locations

Louisiana State University Health Sciences Center-New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Principal Investigator:

Paul G Harch, MD

More Information

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Last update posted

Apr 18, 2017

Last verified

Apr, 2017

Keywords

  • Hyperbaric Oxygen Treatment
  • Mild Traumatic Brain Injury
  • Persistent Post-Concussion Syndrome

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louisiana State University Health Sciences Center in New Orleans on 2017-04-18.