Clinical trial NCT02089594: Hyperbaric Oxygen Treatment to Treat Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)
Official title: Hyperbaric Oxygen Therapy Treatment of Chronic Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post-Concussion Syndrome
Traumatic Brain Injury
Keywords: Hyperbaric Oxygen Treatment
Mild Traumatic Brain Injury
Persistent Post-Concussion Syndrome
Lead sponsor: Louisiana State University Health Sciences Center in New Orleans
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2014-03-18
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized prospective controlled
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Working Memory
timeFrame: One week after final HBOT
measure: Neurobehavioral Symptom Inventory (NSI)
timeFrame: One week after final HBOT
Secondary outcomes:
measure: Wechsler Abbreviated Scale of Intelligence II (WASI-II)
timeFrame: 2 months after final HBOT
measure: Wechsler Memory Scale-IV (WMS-IV
timeFrame: 2 months after final HBOT
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: 2 months after final HBOT
measure: Benton Visual Retention Test with Alternate Forms (Benton VRT)
timeFrame: 2 months after final HBOT
measure: Stroop Color-Word Interference Test
timeFrame: 2 months after final HBOT
measure: Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS)
timeFrame: 2 months after final HBOT
measure: Category Fluency Test (Animal)
timeFrame: 2 months after final HBOT
measure: Automated Neuropsychological Assessment Metrics-4 (ANAM-4)
timeFrame: 2 months after final HBOT
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 months after final HBOT
measure: Quality of Life After Brain Injury (QOLIBRI)
timeFrame: 2 months after final HBOT
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center-New Orleans
state: Louisiana
Study officials:
affiliation: Louisiana State University Health Sciences Center in New Orleans
name: Paul G Harch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.