Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)

This study has been completed.
Sponsor:
Collaborators:
Semper Fi Fund
Marine Corps Law Enforcement Foundation
Coalition to Support America's Heroes
Thirty-eight other contributors
Information provided by (Responsible Party):
Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier:
NCT00760734
First received: September 25, 2008
Last updated: March 30, 2014
Last verified: March 2014
  Purpose

This is a pilot trial to see if one or two 40 treatment courses of low pressure hyperbaric oxygen therapy can improve cognition and brain imaging in subjects with either chronic mild-moderate traumatic brain injury (TBI), also known as post-concussion syndrome (PCS) or chronic PCS with post-traumatic stress disorder (PTSD) secondary to blast injury.


Condition Intervention Phase
TBI (Traumatic Brain Injury)
Post Concussion Syndrome
Post Traumatic Stress Disorder
Chronic Post Traumatic Stress Disorder
Drug: Low pressure hyperbaric oxygen therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Psychometric testing [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SPECT brain imaging [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Quality of life measurements [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Return to school or work [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperbaric oxygen therapy-TBI/PCS
Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT
Drug: Low pressure hyperbaric oxygen therapy
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
Other Name: HBOT
Drug: Low pressure hyperbaric oxygen therapy
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
Other Name: HBOT
Experimental: Hyperbaric Oxygen Therapy-PCS/PTSD
Intervention: Low pressure hyperbaric oxygen therapy, 40 or 80 twice daily, 5d/week, HBOTs at 1.5 ATA/60 minutes each. One month no treatment period between the 40th and 41st HBOT
Drug: Low pressure hyperbaric oxygen therapy
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
Other Name: HBOT
Drug: Low pressure hyperbaric oxygen therapy
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
Other Name: HBOT

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, 18-65 years old
  • One or more mild-moderate TBI's characterized by loss of consciousness due to blast injury that is a minimum of one year old and occurred after 9/11/2001
  • Absence of acute cardiac arrest or hemorrhagic shock at time of TBI.
  • Absence of intracranial neurosurgery post-TBI
  • Disability Rating Scale of 0-3
  • Negative Michigan Alcohol Screening Test (MAST)
  • Negative Drug Abuse Screening Test (DAST)
  • Negative urine toxicology screen for drugs of abuse
  • Negative pregnancy test in females
  • Otherwise good health
  • Less than 90% on the Percent Back to Normal Rating Scale

Exclusion Criteria:

  • Pulmonary disease that precludes HBOT
  • Unstable medical conditions that are contraindicated in HBOT
  • Severe confinement anxiety
  • Pregnancy
  • Other pre-TBI neurological diagnoses
  • Pre or post TBI history of substance abuse
  • Pre or post TBI history of alcoholism.
  • Participation in another experimental trial with active intervention.
  • High probability of inability to complete the experimental protocol.
  • Previous HBOT
  • History of hospitalization for past TBI, stroke, nonfebrile seizures, or any seizure history other than seizure at the time of TBI
  • Past or current history of mental retardation (baseline FSIQ < 71.
  • Pre/post-TBI history of systemic illness with impact on CNS (P.I.'s decision)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760734

Locations
United States, Louisiana
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Sponsors and Collaborators
Paul G. Harch, M.D.
Semper Fi Fund
Marine Corps Law Enforcement Foundation
Coalition to Support America's Heroes
Thirty-eight other contributors
Investigators
Principal Investigator: Paul G Harch, M.D. Louisiana State University Health Sciences Center in New Orleans
  More Information

Additional Information:
Publications:
Responsible Party: Paul G. Harch, M.D., Clinical Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans
ClinicalTrials.gov Identifier: NCT00760734     History of Changes
Other Study ID Numbers: LSU IRB #7051
Study First Received: September 25, 2008
Last Updated: March 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
Chronic traumatic brain injury
Post concussion syndrome
Post traumatic stress disorder
Chronic post traumatic stress disorder

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Brain Injuries
Post-Concussion Syndrome
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Concussion
Head Injuries, Closed
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on April 21, 2014