Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI) (HBOT)
Primary Purpose
Mild Traumatic Brain Injury, Post-Concussive Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Traumatic Brain Injury, Veterans, Hyperbaric Oxygen Treatment, OEF/OIF, Post-Concussive Symptoms, Blast Exposure
Eligibility Criteria
Inclusion Criteria:
- Post-Deployment status after having served in OIF/OEF
- 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]
- Diagnosis of MTBI within 3 years as confirmed by the TBI specialty team at the Richmond VAMC
- Presence of post-concussive symptoms from MTBI, confirmed by the VCU-CERSE team at the Richmond VAMC, for at least 3 months
- Medical clearance to undergo hyperbaric oxygen treatment
- Stable mental status for at least one month
- Stable psychotropic medication history for at least one month
- Ability to perform neuropsychologic testing battery
- Ability to tolerate neurophysiological and neuroimaging battery
Exclusion Criteria:
- Traumatic Brain Injury with a primary etiology other than blast
- 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.)
- Past history of moderate or severe TBI
- Active diagnosis of Post-traumatic Stress Disorder
- Active diagnosis of Generalized Anxiety Disorder
- Active Psychosis
- Past history of Schizophrenia
- Pre-existing PCS
- Previous hyperbaric oxygen treatments
- 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
- Active use of cancer medications
- Pregnancy
Sites / Locations
- Naval Medical Center Portsmouth
- Hunter Holmes McGuire Veterans' Affairs Medical Center
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Treatment 1--1.5 atm abs
Treatment 2--2.0 atm abs
Placebo--equivalent to breathing air
Arm Description
Outcomes
Primary Outcome Measures
Improvement on symptom assessment battery
Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale
Improvement on symptom assessment battery
Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale
Improvement on symptom assessment battery
Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale
Secondary Outcome Measures
Neuropsychological Testing Battery
Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging and Eye tracking
Common Military Task Tests
Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock
Neuropsychological Testing Battery
Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking
Neuropsychological Testing Battery
Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking
Common Military Task Tests
Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock
Common Military Task Tests
Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock
Full Information
NCT ID
NCT01220713
First Posted
October 6, 2010
Last Updated
August 26, 2013
Sponsor
Virginia Commonwealth University
Collaborators
United States Naval Medical Center, Portsmouth, Hunter Holmes Mcguire Veteran Affairs Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01220713
Brief Title
Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)
Acronym
HBOT
Official Title
Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI): A Randomized, Double-Blinded, Sham Controlled, Variable Dose, Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
United States Naval Medical Center, Portsmouth, Hunter Holmes Mcguire Veteran Affairs Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this research is to serve as a demonstration project to determine the tolerability of individuals with persistent post-concussive symptoms from combat-related mild TBI (traumatic brain injury), identify dose-finding for HBO2 (Hyperbaric Oxygen) therapy, and determine the efficacy of HBO2 therapy.
Detailed Description
Persistent post-concussive symptoms from mild traumatic brain injury are a severe issue facing the readiness, retention and quality of life of Department of Defense(DoD) service members and Veterans. The inadequacy of established treatment regimens and evidence-based science in post-concussive symptoms (PCS)/MTBI is forcing a closer look at non-conventional treatments of this condition. Hyperbaric oxygen (HBO2) is a potent intervention with demonstrated efficacy in dive-related injuries, soft tissue healing, and carbon monoxide poisoning.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury, Post-Concussive Syndrome
Keywords
Traumatic Brain Injury, Veterans, Hyperbaric Oxygen Treatment, OEF/OIF, Post-Concussive Symptoms, Blast Exposure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment 1--1.5 atm abs
Arm Type
Experimental
Arm Title
Treatment 2--2.0 atm abs
Arm Type
Experimental
Arm Title
Placebo--equivalent to breathing air
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improvement on symptom assessment battery
Description
Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale
Time Frame
2-4 weeks before treatment
Title
Improvement on symptom assessment battery
Description
Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale
Time Frame
24-72 hours after final treatment
Title
Improvement on symptom assessment battery
Description
Symptom Assessment Battery include: Rivermead Postconcussive Symptom Questionnaire, Pain Intensity Numerical 0-10 scale, Alcohol Use Disorders Test-Consumption, McGill Pain Questionnaire-Short Form, The Center for Epidemiological Studies Depression Scale, PTSD Checklist-Military Version, Extended Glasgow Outcome Scale, Mayo-Portland Adaptability Inventory 4, Satisfaction With Life Scale
Time Frame
3 months after final treatment.
Secondary Outcome Measure Information:
Title
Neuropsychological Testing Battery
Description
Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised
Time Frame
2-4 weeks before treatment
Title
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging and Eye tracking
Time Frame
24-72 hours after final treatment
Title
Common Military Task Tests
Description
Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock
Time Frame
2-4 weeks before treatment
Title
Neuropsychological Testing Battery
Description
Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised
Time Frame
24-72 hours after final treatment
Title
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking
Time Frame
3 months after final treatment.
Title
Neuropsychological Testing Battery
Description
Test Battery Includes: Trail Making Test, Stroop Classic, California Verbal Learning Test-II, Wechsler Test of Adult Reading, Wechsler Adult Intelligence Scale III (WAIS-III): Digit Symbol Coding Digit Span Letter-Number Sequencing Symbol Search and Arithmetic, Delis-Kaplan Executive Functioning System(D-KEFS): Controlled Oral Word Exam (COWA), Grooved Pedboard, Test of Memory Malingering, Benton Visual Memory Test-Revised
Time Frame
3 months after final treatment.
Title
Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking
Time Frame
2-4 weeks before treatment
Title
Common Military Task Tests
Description
Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock
Time Frame
24-72 hours after final treatment
Title
Common Military Task Tests
Description
Testing includes: Mission-oriented protective posture (MOPP) gear donning, Protective mask usage, personal weapon assembly/dis-assembly, grenade inspection/identification, acute management of injury-induced shock
Time Frame
3 months after final treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post-Deployment status after having served in OIF/OEF
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]
Diagnosis of MTBI within 3 years as confirmed by the TBI specialty team at the Richmond VAMC
Presence of post-concussive symptoms from MTBI, confirmed by the VCU-CERSE team at the Richmond VAMC, for at least 3 months
Medical clearance to undergo hyperbaric oxygen treatment
Stable mental status for at least one month
Stable psychotropic medication history for at least one month
Ability to perform neuropsychologic testing battery
Ability to tolerate neurophysiological and neuroimaging battery
Exclusion Criteria:
Traumatic Brain Injury with a primary etiology other than blast
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.)
Past history of moderate or severe TBI
Active diagnosis of Post-traumatic Stress Disorder
Active diagnosis of Generalized Anxiety Disorder
Active Psychosis
Past history of Schizophrenia
Pre-existing PCS
Previous hyperbaric oxygen treatments
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
Active use of cancer medications
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David X Cifu, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brett Hart, MD
Organizational Affiliation
Naval Operational Medicine Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelle Nichols, MSN, RN
Organizational Affiliation
McGuire Veterans' Affairs Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Justin O Alicea
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Steven L West, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Director
Facility Information:
Facility Name
Naval Medical Center Portsmouth
City
Portsmouth
State/Province
Virginia
Country
United States
Facility Name
Hunter Holmes McGuire Veterans' Affairs Medical Center
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)
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