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

Phase 3

• Conditions: Post-Concussion Syndrome; Traumatic Brain Injury
• Interventions: Drug: Hyperbaric Oxygen; Drug: No Hyperbaric Oxygen

• Registration Number: NCT02089594
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

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.

Study Timeline

• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-18
• Study Start: 2014-05
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-16
• Last Update Posted: 2017-04-18
• Primary Completion: 2018-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
No Hyperbaric Oxygen Treatment (HBOT)	No Hyperbaric Oxygen	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.
No Hyperbaric Oxygen Treatment (HBOT)	Hyperbaric Oxygen	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.
Hyperbaric Oxygen Therapy (HBOT)	Hyperbaric Oxygen	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.

Primary Outcome Measures

Name	Time	Method
Working Memory	One week after final HBOT
Neurobehavioral Symptom Inventory (NSI)	One week after final HBOT

Secondary Outcome Measures

Name	Time	Method
Wechsler Abbreviated Scale of Intelligence II (WASI-II)	2 months after final HBOT
Wechsler Memory Scale-IV (WMS-IV	2 months after final HBOT
Rey Auditory Verbal Learning Test (RAVLT)	2 months after final HBOT
Benton Visual Retention Test with Alternate Forms (Benton VRT)	2 months after final HBOT
Stroop Color-Word Interference Test	2 months after final HBOT
Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS)	2 months after final HBOT
Category Fluency Test (Animal)	2 months after final HBOT
Automated Neuropsychological Assessment Metrics-4 (ANAM-4)	2 months after final HBOT
Pittsburgh Sleep Quality Index (PSQI)	2 months after final HBOT
Quality of Life After Brain Injury (QOLIBRI)	2 months after final HBOT

Trial Locations

Locations (1)

Louisiana State University Health Sciences Center-New Orleans; 🇺🇸 New Orleans, Louisiana, United States