Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI) (HBOT)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Virginia Commonwealth University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Virginia Commonwealth University
Collaborators:
United States Naval Medical Center, Portsmouth
Hunter Holmes Mcguire Veteran Affairs Medical Center
Information provided by:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01220713
First received: October 6, 2010
Last updated: October 12, 2010
Last verified: October 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mild Traumatic Brain Injury Post-Concussive Syndrome |
Procedure: Hyperbaric Oxygen Therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Virginia Commonwealth University:
Primary Outcome Measures:
- Improvement on symptom assessment battery [ Time Frame: 2-4 weeks before treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 24-72 hours after final treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months after final treatment. ] [ Designated as safety issue: No ]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 [ Time Frame: 2-4 weeks before treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 24-72 hours after final treatment ] [ Designated as safety issue: No ]
- Common Military Task Tests [ Time Frame: 2-4 weeks before treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 24-72 hours after final treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months after final treatment. ] [ Designated as safety issue: No ]
- Neuropsychological Testing Battery [ Time Frame: 3 months after final treatment. ] [ Designated as safety issue: No ]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 [ Time Frame: 2-4 weeks before treatment ] [ Designated as safety issue: No ]
- Common Military Task Tests [ Time Frame: 24-72 hours after final treatment ] [ Designated as safety issue: No ]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 [ Time Frame: 3 months after final treatment. ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment 1--1.5 atm abs |
Procedure: 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.
|
| Experimental: Treatment 2--2.0 atm abs |
Procedure: 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.
|
| Sham Comparator: Placebo--equivalent to breathing air |
Procedure: 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.
|
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.
Eligibility| Ages Eligible for Study: | 19 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220713
Contacts
| Contact: Justin Alicea | 804 628 1355 | joalicea@vcu.edu |
| Contact: Steven West, PhD | 804 827 2562 | slwest2@vcu.edu |
Locations
| United States, Virginia | |
| Naval Medical Center Portsmouth | Recruiting |
| Portsmouth, Virginia, United States | |
| Contact: Brett Hart, MD brett.hart@med.navy.mil | |
| Principal Investigator: Brett Hart, MD | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States | |
| Contact: Justin Alicea 804-628-1355 joalicea@vcu.edu | |
| Contact: Steven West, PhD 804 827 2562 slwest2@vcu.edu | |
| Principal Investigator: David Cifu, MD | |
| Hunter Holmes McGuire Veterans' Affairs Medical Center | Recruiting |
| Richmond, Virginia, United States | |
| Contact: Michelle Nicholls, MSN, RN michelle.nichols@va.gov | |
| Principal Investigator: Michelle Nicholls, MSN, RN | |
Sponsors and Collaborators
Virginia Commonwealth University
United States Naval Medical Center, Portsmouth
Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
| Principal Investigator: | David X Cifu, MD | Virginia Commonwealth University |
| Principal Investigator: | Brett Hart, MD | Naval Operational Medicine Institute |
| Principal Investigator: | Michelle Nichols, MSN, RN | McGuire Veterans' Affairs Medical Center |
| Study Director: | Justin O Alicea | Virginia Commonwealth University |
| Study Director: | Steven L West, PhD | Virginia Commonwealth University |
More Information
No publications provided
| Responsible Party: | Dr. David X. Cifu, MD, Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT01220713 History of Changes |
| Other Study ID Numbers: | N66001-09-2-2060, 01609, NOMI.2010.002, HM12204 |
| Study First Received: | October 6, 2010 |
| Last Updated: | October 12, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
|
Traumatic Brain Injury Veterans Hyperbaric Oxygen Treatment |
OEF/OIF Post-Concussive Symptoms Blast Exposure |
Additional relevant MeSH terms:
|
Brain Injuries Post-Concussion Syndrome Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma |
Trauma, Nervous System Wounds and Injuries Brain Concussion Head Injuries, Closed Wounds, Nonpenetrating |
ClinicalTrials.gov processed this record on June 17, 2013