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

Last updated: April 16, 2017
Sponsor: Louisiana State University Health Sciences Center in New Orleans
Overall Status: Trial Status Unknown

Phase

3

Condition

Neurologic Disorders

Traumatic Brain Injury

Brain Injury

Treatment

N/A

Clinical Study ID

NCT02089594
LSU IRB #7381
W81XWH-10-1-0962
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 aglobal ischemic insult to the TBI.

  8. Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug AbuseScreening 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 negativeurinalysis result in order to start or continue treatment.

  11. Subjects must be legally responsible, speak and understand English fluently, and beable to sign their own consent documents.

  12. Otherwise good health.

Exclusion

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 congestiveheart failure or heart failure requiring hospital emergency evaluation or admission inthe previous year).

  3. Severe confinement anxiety (e.g., patients who require anesthesia conscious sedationfor MRI).

  4. Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerativediseases, 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. terminalcondition or inability to complete outcome instruments).

  7. Previous HBOT.

  8. History of hospitalization for past stroke, non-febrile seizures, or any seizurehistory 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 timeof 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

Total Participants: 59
Study Start date:
May 01, 2014
Estimated Completion Date:
March 31, 2019

Study 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.

Connect with a study center

  • Louisiana State University Health Sciences Center-New Orleans

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

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