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

NCT02089594 | Unknown Phase 3 DMC

• 2 other identifiers: LSU IRB #7381W81XWH-10-1-0962
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Working Memory

  One week after final HBOT

• Neurobehavioral Symptom Inventory (NSI)

  One week after final HBOT

Secondary Outcomes (10)

• 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

Study Arms (2)

Hyperbaric Oxygen Therapy (HBOT)

EXPERIMENTAL

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.

Drug: Hyperbaric Oxygen

No Hyperbaric Oxygen Treatment (HBOT)

EXPERIMENTAL

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.

Drug: Hyperbaric Oxygen; Drug: No Hyperbaric Oxygen

Interventions

Hyperbaric Oxygen 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.

Also known as: Hyperbaric Oxygen Therapy

Hyperbaric Oxygen Therapy (HBOT); No Hyperbaric Oxygen Treatment (HBOT)

No Hyperbaric Oxygen 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.

Also known as: Hyperbaric Oxygen Therapy

No Hyperbaric Oxygen Treatment (HBOT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults, 18-65 years old.
• One or more mild TBI's due to blunt or blast injury.
• Meets criteria for PPCS.
• Ability to complete the NSI.
• Ability to complete the PCL-M or C.
• Ability to complete CAPS if needed.
• Absence of acute cardiac arrest or hemorrhagic shock at time of TBI that would cause a global ischemic insult to the TBI.
• Ability to complete the Michigan Alcohol Screening Test( MAST) and Drug Abuse Screening Test (DAST).
• Ability to complete a urine toxicology screen for drugs of abuse.
• Negative pregnancy test in females. Female subjects will need to have a negative urinalysis result in order to start or continue treatment.
• Subjects must be legally responsible, speak and understand English fluently, and be able to sign their own consent documents.
• Otherwise good health.

You may not qualify if:

• Pulmonary disease that precludes HBOT (e.g., bronchospasm unresponsive to medication, bullous emphysema).
• 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).
• Severe confinement anxiety (e.g., patients who require anesthesia conscious sedation for MRI).
• Other pre-TBI cerebral neurological diagnoses including stroke, dementia, degenerative diseases, multiple sclerosis, congenital neurological disorder.
• Participation in another experimental trial with active intervention.
• High probability of inability to complete the experimental protocol (e.g. terminal condition or inability to complete outcome instruments).
• Previous HBOT.
• History of hospitalization for past stroke, non-febrile seizures, or any seizure history other than seizure at the time of TBI.
• Past or current history of mental retardation.
• Pre-/post-TBI history of systemic illness with impact on central nervous system (P.I.'s decision).
• 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.
• Any concurrent systemic illness whose symptomatology confounds the diagnosis of PPCS (P.I.'s decision).
• Active malignancy undergoing treatment.
• Taking lithium.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Louisiana State University Health Sciences Center-New Orleans

New Orleans, Louisiana, 70112, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 32189664 DERIVED

MeSH Terms

Conditions

Post-Concussion Syndrome; Brain Injuries, Traumatic; Brain Concussion

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Paul G Harch, MD

  Louisiana State University Health Sciences Center in New Orleans

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cara J Rowe, MSW

CONTACT

504-427-5632; cjoh26@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Neuropsychological testers and neuropsychologist blinded to treatment group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Medicine

Model Details: Randomized prospective controlled

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 18, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

US (1)