Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)
NCT ID: NCT01220713
Last Updated: 2013-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-06-30
2013-07-31
Brief Summary
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Detailed Description
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This study is prospective, randomized, double-blinded and controlled. A total of 60 subjects will be randomly assigned to one of three treatment arms of the study: 20 subjects into the 1.5 atm abs oxygen equivalent HBO2 treatment, 20 subjects into the 2.0 atm abs oxygen equivalent HBO2 treatment and 20 subjects into the sham treatment (a placebo exposure equivalent to breathing atmospheric air). The protocol utilizes a pre- and post-treatment comprehensive performance battery that will allow for meaningful clinical outcomes and a broad understanding of the effects of the treatment. This project represents a collaboration between the Department of Defense (DoD), the Richmond Veterans Administration Medical Center (VAMC) and Virginia Commonwealth University. Service members will be recruited from military bases/treatment facilities (MTF), receive hyperbaric oxygen at existing DoD hyperbaric chambers and be evaluated by the established Virginia Commonwealth University-Center for Rehabilitation Sciences and Engineering (CERSE), a collaborative research center co-located at the Richmond VAMC and VCU.
Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Treatment 1--1.5 atm abs
Hyperbaric Oxygen Therapy
1.5 atm abs oxygen equivalent of 75% oxygen (balance 25% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Treatment 2--2.0 atm abs
Hyperbaric Oxygen Therapy
2.0 atm abs oxygen equivalent of 100% oxygen (no nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Placebo--equivalent to breathing air
Hyperbaric Oxygen Therapy
sham--air equivalent of 10.5% oxygen (balance 89.5% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Interventions
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Hyperbaric Oxygen Therapy
1.5 atm abs oxygen equivalent of 75% oxygen (balance 25% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Hyperbaric Oxygen Therapy
2.0 atm abs oxygen equivalent of 100% oxygen (no nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Hyperbaric Oxygen Therapy
sham--air equivalent of 10.5% oxygen (balance 89.5% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
Eligibility Criteria
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Inclusion Criteria
2. Blast Event within past 3 years during OIF/OEF deployment \[event defined as any of the following symptoms or experiences occurring during or shortly after the blast or explosion: dazed, confused, saw stars, headache, dizziness, irritability, memory gap (not remembering injury or injury period), hearing loss, abdominal pain, shortness of breath, struck by debris, knocked over or down, knocked into or against something, helmet damaged, evacuated\]
3. Diagnosis of MTBI within 3 years as confirmed by the TBI specialty team at the Richmond VAMC
4. Presence of post-concussive symptoms from MTBI, confirmed by the VCU-CERSE team at the Richmond VAMC, for at least 3 months
5. Medical clearance to undergo hyperbaric oxygen treatment
6. Stable mental status for at least one month
7. Stable psychotropic medication history for at least one month
8. Ability to perform neuropsychologic testing battery
9. Ability to tolerate neurophysiological and neuroimaging battery
Exclusion Criteria
2. Moderate or Severe TBI (moderate or severe brain injury defined as best Glasgow Coma Score in first 24 hours \< 12, , brain bleeding or blood clot (i.e., abnormal brain CT scan), or none of first week after event can be remembered.)
3. Past history of moderate or severe TBI
4. Active diagnosis of Post-traumatic Stress Disorder
5. Active diagnosis of Generalized Anxiety Disorder
6. Active Psychosis
7. Past history of Schizophrenia
8. Pre-existing PCS
9. Previous hyperbaric oxygen treatments
10. Contraindications to HBO2, including any "air trapping" pulmonary problems, inability to equalize middle ear and sinuses, or patients who are claustrophobic and require anti-anxiety medication for the condition
11. Active use of cancer medications
12. Pregnancy
19 Years
60 Years
ALL
No
Sponsors
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United States Naval Medical Center, Portsmouth
FED
Hunter Holmes Mcguire Veteran Affairs Medical Center
FED
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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David X Cifu, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Brett Hart, MD
Role: PRINCIPAL_INVESTIGATOR
Naval Operational Medicine Institute
Michelle Nichols, MSN, RN
Role: PRINCIPAL_INVESTIGATOR
McGuire Veterans' Affairs Medical Center
Justin O Alicea
Role: STUDY_DIRECTOR
Virginia Commonwealth University
Steven L West, PhD
Role: STUDY_DIRECTOR
Virginia Commonwealth University
Locations
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Naval Medical Center Portsmouth
Portsmouth, Virginia, United States
Hunter Holmes McGuire Veterans' Affairs Medical Center
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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01609
Identifier Type: OTHER
Identifier Source: secondary_id
NOMI.2010.002
Identifier Type: OTHER
Identifier Source: secondary_id
HM12204
Identifier Type: OTHER
Identifier Source: secondary_id
N66001-09-2-2060
Identifier Type: -
Identifier Source: org_study_id