HBOT: Hyperbaric Oxygen Therapy (HBO2T) for Post-Concussive Symptoms (PSC) After Mild Traumatic Brain Injury (mTBI)

• Sponsor: Virginia Commonwealth University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01220713
• Collaborator: United States Naval Medical Center, Portsmouth (U.S. Fed), Hunter Holmes Mcguire Veteran Affairs Medical Center (U.S. Fed)
• Enrollment: 60
• Locations: 3
• Arms: 3
• Duration (Months): 37
• Patients Per Site: 20
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Traumatic Brain Injury; Post-Concussive Syndrome	Procedure: Hyperbaric Oxygen Therapy; Procedure: Hyperbaric Oxygen Therapy; Procedure: Hyperbaric Oxygen Therapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, 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
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Improvement on symptom assessment battery [2-4 weeks before treatment]

   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

2. Improvement on symptom assessment battery [24-72 hours after final treatment]

   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

3. Improvement on symptom assessment battery [3 months after final treatment.]

   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

1. Neuropsychological Testing Battery [2-4 weeks before treatment]

   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

2. Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging and Eye tracking [24-72 hours after final treatment]

3. Common Military Task Tests [2-4 weeks before treatment]

   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

4. Neuropsychological Testing Battery [24-72 hours after final treatment]

   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

5. Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking [3 months after final treatment.]

6. Neuropsychological Testing Battery [3 months after final treatment.]

   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

7. Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking [2-4 weeks before treatment]

8. Common Military Task Tests [24-72 hours after final treatment]

   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

9. Common Military Task Tests [3 months after final treatment.]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Post-Deployment status after having served in OIF/OEF

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:

1. Traumatic Brain Injury with a primary etiology other than blast

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Naval Medical Center Portsmouth	Portsmouth	Virginia	United States
2	Hunter Holmes McGuire Veterans' Affairs Medical Center	Richmond	Virginia	United States
3	Virginia Commonwealth University	Richmond	Virginia	United States

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT01220713
• Other Study ID Numbers: N66001-09-2-2060; 01609; NOMI.2010.002; HM12204
• First Posted: Oct 14, 2010
• Last Update Posted: Aug 27, 2013
• Last Verified: Aug 1, 2013

• 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; Brain Injuries, Traumatic; Brain Concussion; Post-Concussion Syndrome; Wounds and Injuries

Study Results

No Results Posted as of Aug 27, 2013