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

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ClinicalTrials.gov Identifier: NCT00760734
Recruitment Status : Completed
First Posted : September 26, 2008
Last Update Posted : April 18, 2017
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

Tracking Information
First Submitted Date  ICMJE September 25, 2008
First Posted Date  ICMJE September 26, 2008
Last Update Posted Date April 18, 2017
Study Start Date  ICMJE September 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2008)
Psychometric testing [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00760734 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2008)
  • SPECT brain imaging [ Time Frame: 30 days ]
  • Quality of life measurements [ Time Frame: 30 days ]
  • Return to school or work [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
Official Title  ICMJE HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • TBI (Traumatic Brain Injury)
  • Post Concussion Syndrome
  • Post Traumatic Stress Disorder
  • Chronic Post Traumatic Stress Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Drug: Low pressure hyperbaric oxygen therapy
    • Drug: Low pressure hyperbaric oxygen therapy
  • 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
    Interventions:
    • Drug: Low pressure hyperbaric oxygen therapy
    • Drug: Low pressure hyperbaric oxygen therapy
Publications * Harch PG, Andrews SR, Fogarty EF, Amen D, Pezzullo JC, Lucarini J, Aubrey C, Taylor DV, Staab PK, Van Meter KW. A phase I study of low-pressure hyperbaric oxygen therapy for blast-induced post-concussion syndrome and post-traumatic stress disorder. J Neurotrauma. 2012 Jan 1;29(1):168-85. doi: 10.1089/neu.2011.1895. Epub 2011 Nov 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 25, 2008)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00760734
Other Study ID Numbers  ICMJE LSU IRB #7051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paul G. Harch, M.D., Louisiana State University Health Sciences Center in New Orleans
Study Sponsor  ICMJE Paul G. Harch, M.D.
Collaborators  ICMJE
  • Semper Fi Fund
  • Marine Corps-Law Enforcement Foundation
  • Coalition to Support America's Heroes
  • Thirty-eight other contributors
Investigators  ICMJE
Principal Investigator: Paul G Harch, M.D. Louisiana State University Health Sciences Center in New Orleans
PRS Account Louisiana State University Health Sciences Center in New Orleans
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP