Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
Primary Purpose
TBI (Traumatic Brain Injury), Post Concussion Syndrome, Post Traumatic Stress Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Low pressure hyperbaric oxygen therapy
Low pressure hyperbaric oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for TBI (Traumatic Brain Injury) focused on measuring Chronic traumatic brain injury, Post concussion syndrome, Post traumatic stress disorder, Chronic post traumatic stress disorder
Eligibility 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)
Sites / Locations
- LSU Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Hyperbaric oxygen therapy-TBI/PCS
Hyperbaric Oxygen Therapy-PCS/PTSD
Arm Description
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
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
Outcomes
Primary Outcome Measures
Psychometric testing
Secondary Outcome Measures
SPECT brain imaging
Quality of life measurements
Return to school or work
Full Information
NCT ID
NCT00760734
First Posted
September 25, 2008
Last Updated
April 16, 2017
Sponsor
Paul G. Harch, M.D.
Collaborators
Semper Fi Fund, Marine Corps-Law Enforcement Foundation, Coalition to Support America's Heroes, Thirty-eight other contributors
1. Study Identification
Unique Protocol Identification Number
NCT00760734
Brief Title
Hyperbaric Oxygen Therapy (HBOT) in Chronic Traumatic Brain Injury (TBI)/Post Concussion Syndrome (PCS) and TBI/Post-Traumatic Stress Disorder (PTSD)
Official Title
HBOT in Chronic Traumatic Brain Injury/Post Concussion Syndrome and TBI/PTSD Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul G. Harch, M.D.
Collaborators
Semper Fi Fund, Marine Corps-Law Enforcement Foundation, Coalition to Support America's Heroes, Thirty-eight other contributors
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury), Post Concussion Syndrome, Post Traumatic Stress Disorder, Chronic Post Traumatic Stress Disorder
Keywords
Chronic traumatic brain injury, Post concussion syndrome, Post traumatic stress disorder, Chronic post traumatic stress disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperbaric oxygen therapy-TBI/PCS
Arm Type
Experimental
Arm Description
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
Arm Title
Hyperbaric Oxygen Therapy-PCS/PTSD
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Low pressure hyperbaric oxygen therapy
Other Intervention Name(s)
HBOT
Intervention Description
HBOT at 1.5 ATA/60 minutes twice/day, five days/week for 40 or 80 treatments
Intervention Type
Drug
Intervention Name(s)
Low pressure hyperbaric oxygen therapy
Other Intervention Name(s)
HBOT
Intervention Description
HBOT: 1.5 ATA/60 minutes twice/day, 5 days/week for 40 or 80 treatments
Primary Outcome Measure Information:
Title
Psychometric testing
Time Frame
30 days
Secondary Outcome Measure Information:
Title
SPECT brain imaging
Time Frame
30 days
Title
Quality of life measurements
Time Frame
30 days
Title
Return to school or work
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G Harch, M.D.
Organizational Affiliation
Louisiana State University Health Sciences Center in New Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22026588
Citation
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.
Results Reference
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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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