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

NCT01220713 | Completed Phase 2 DMC

• 4 other identifiers: N66001-09-2-206001609NOMI.2010.002HM12204
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Mild Traumatic Brain Injury; Post-Concussive Syndrome

Keywords

Traumatic Brain Injury; Veterans; Hyperbaric Oxygen Treatment; OEF/OIF; Post-Concussive Symptoms; Blast Exposure

Outcome Measures

Primary Outcomes (3)

• 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

  2-4 weeks before treatment

• 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

  24-72 hours after final treatment

• 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

  3 months after final treatment.

Secondary Outcomes (9)

• Neuropsychological Testing Battery

  2-4 weeks before treatment

• Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging and Eye tracking

  24-72 hours after final treatment

• Common Military Task Tests

  2-4 weeks before treatment

• Neuropsychological Testing Battery

  24-72 hours after final treatment

• Neurophysiologic Measures of Human Performance: Computerized Posturography, NeuroImaging, Eye tracking

  3 months after final treatment.

Study Arms (3)

Treatment 1--1.5 atm abs

EXPERIMENTAL

Procedure: Hyperbaric Oxygen Therapy

Treatment 2--2.0 atm abs

EXPERIMENTAL

Procedure: Hyperbaric Oxygen Therapy

Placebo--equivalent to breathing air

SHAM COMPARATOR

Procedure: Hyperbaric Oxygen Therapy

Interventions

Hyperbaric Oxygen Therapy PROCEDURE

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 1--1.5 atm abs

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• United States Naval Medical Center, Portsmouth: collaborator
• Hunter Holmes Mcguire Veteran Affairs Medical Center: collaborator

Study Sites (3)

Naval Medical Center Portsmouth

Portsmouth, Virginia, United States

Location

Hunter Holmes McGuire Veterans' Affairs Medical Center

Richmond, Virginia, United States

Location

Virginia Commonwealth University

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome; Brain Injuries, Traumatic

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Justin O Alicea

  Virginia Commonwealth University

  STUDY DIRECTOR

• Steven L West, PhD

  Virginia Commonwealth University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2010
• First Posted: October 14, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 27, 2013

Record last verified: 2013-08

Locations

US (3)