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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Louisiana State University Health Sciences Center in New Orleans
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT02089594
First received: March 14, 2014
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention Phase
Post-Concussion Syndrome
Traumatic Brain Injury
Drug: Hyperbaric Oxygen
Drug: No Hyperbaric Oxygen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy Treatment of Chronic Mild Traumatic Brain Injury (mTBI)/Persistent Post-Concussion Syndrome (PPCS)

Resource links provided by NLM:


Further study details as provided by Louisiana State University Health Sciences Center in New Orleans:

Primary Outcome Measures:
  • Working Memory [ Time Frame: One week after final HBOT ] [ Designated as safety issue: No ]
  • Neurobehavioral Symptom Inventory (NSI) [ Time Frame: One week after final HBOT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wechsler Abbreviated Scale of Intelligence II (WASI-II) [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Wechsler Memory Scale-IV (WMS-IV [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Rey Auditory Verbal Learning Test (RAVLT) [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Benton Visual Retention Test with Alternate Forms (Benton VRT) [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Stroop Color-Word Interference Test [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Controlled Oral Word Association Test, Letters F, A, and S (COWAT-FAS) [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Category Fluency Test (Animal) [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Automated Neuropsychological Assessment Metrics-4 (ANAM-4) [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]
  • Quality of Life After Brain Injury (QOLIBRI) [ Time Frame: 2 months after final HBOT ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
Other Name: Hyperbaric Oxygen Therapy
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.
Drug: 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.
Other Name: Hyperbaric Oxygen Therapy
Drug: 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.
Other Name: Hyperbaric Oxygen Therapy

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089594

Contacts
Contact: Cara J Rowe, MSW 504-427-5632 cjoh26@lsuhsc.edu

Locations
United States, Louisiana
Louisiana State University Health Sciences Center-New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: Paul G Harch, MD         
Sub-Investigator: Susan Andrews, PhD         
Sponsors and Collaborators
Louisiana State University Health Sciences Center in New Orleans
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Paul G Harch, MD Louisiana State University Health Sciences Center in New Orleans
  More Information

Additional Information:
No publications provided

Responsible Party: Paul G. Harch, M.D., Clinical Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT02089594     History of Changes
Other Study ID Numbers: LSU IRB #7381, W81XWH-10-1-0962
Study First Received: March 14, 2014
Last Updated: June 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
Hyperbaric Oxygen Treatment
Mild Traumatic Brain Injury
Persistent Post-Concussion Syndrome

Additional relevant MeSH terms:
Syndrome
Brain Injuries
Post-Concussion Syndrome
Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on September 18, 2014