mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms - Full Text View

Purpose

Purpose of this study is to investigate the mechanisms of action of hyperbaric oxygen therapy for persistent post-concussive symptoms after mild tramatic brains injury

Condition	Intervention	Phase
Traumatic Brain Injury With Brief Loss of Consciousness Post-Concussion Syndrome	Drug: hyperbaric oxygen 1.5 atms Drug: sham control 21%o2 room air	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	Brain Injury and Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms After Mild Traumatic Brain Injury (BIMA) Protocol

Resource links provided by NLM:

MedlinePlus related topics: Oxygen Therapy Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:

Change from baseline at 13 weeks and 6 months of neuropsychiatric measures [ Time Frame: 12 months, 40 HBO2 sessions ] [ Designated as safety issue: No ]
Additionally, this study will describe the brain function and anatomy of active duty personnel with PCS who are symptomatic at least 3 months but no more than 5 years after mild traumatic brain injury using a comprehensive battery of assessments, across time, in groups randomized to receive intervention (hyperbaric oxygen) or sham control, and explore potential associations between changes in function, anatomy, and participant reported outcomes.

Secondary Outcome Measures:

compare rates of change in neuropsychiatric measure between treatment and sham [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To evaluate safety of the proposed hyperbaric oxygen versus sham interventions
- To identify practical issues in instituting assessments among participants with PCS and to address related logistical considerations prior to initiating the pivotal study.
- To compare outcome assessment results to a normative population, without history of traumatic brain injury (TBI), comprehensively assessed in a similar fashion in a companion study.

Estimated Enrollment:	72
Study Start Date:	September 2012
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HBO2 at 1.5 atms stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized	Drug: hyperbaric oxygen 1.5 atms the active group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen)Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.
Sham Comparator: Sham Control 1.2 atms Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs),	Drug: sham control 21%o2 room air The chamber will be compressed with air to 1.2 atm abs to simulate the active group.participants will don a hood and breathe 21% oxygen (room air).Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs),

Arms

Assigned Interventions

Experimental: HBO2 at 1.5 atms

stratified by site and time from injury (less than one year versus one year or more), in which participants are randomized

Drug: hyperbaric oxygen 1.5 atms

the active group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen)Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.

Sham Comparator: Sham Control 1.2 atms

Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs),

Drug: sham control 21%o2 room air

The chamber will be compressed with air to 1.2 atm abs to simulate the active group.participants will don a hood and breathe 21% oxygen (room air).Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs),

Detailed Description:

Under an IND held by the Office of the Army Surgeon General (IND 104,678), this study (BIMA) will obtain pilot data that will complement results from another pilot study (HOPPS). Results from BIMA and HOPPS will be used to select primary and secondary endpoints for a subsequent phase III efficacy trial of hyperbaric oxygen versus sham control for the treatment of post concussive syndrome (PCS). Ideal endpoint candidates will have properties that suggest an association with a neurologic mechanism.

• Additionally, this study will describe the brain function and anatomy of active duty personnel with PCS who are symptomatic at least 3 months but no more than 5 years after mild traumatic brain injury using a comprehensive battery of assessments, across time, in groups randomized to receive intervention (hyperbaric oxygen) or sham control, and explore potential associations between changes in function, anatomy, and participant reported outcomes.

Secondary:

To evaluate safety of the proposed hyperbaric oxygen and sham interventions
To identify practical issues in instituting assessments among participants with PCS and to address related logistical considerations prior to initiating the pivotal study.
To compare outcome assessment results to a normative population, without history of traumatic brain injury (TBI), comprehensively assessed in a similar fashion in a companion study.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

On Active Duty (TRICARE beneficiary
Able to equalize middle ear pressure
Able to speak and read English, as primary language.
Agrees to and appears able to participate in all outcome assessments.
Agrees to provide blood samples for clinical lab tests.
Demonstrates the ability to offer informed consent and sign consent stationed outside the Colorado Springs, Colorado area must be willing and able to travel
Participants must have a history of at least one (minimum requirement) mild traumatic brain injury (mTBI) with persistent symptoms that meets all the following criteria:
- Brain injury that occurred more than 3 months prior to baseline screening at the local site, with the most recent injury occurring no more than 5 years prior to randomization.
- Most recent traumatic brain injury (TBI) occurred on active duty.
- TBI was caused by non-penetrating trauma or blast exposure.
- TBI resulted in at least one of the following at the time of injury: a period of loss of or a decreased level of consciousness (up to 30 minutes); a loss of memory for events immediately before or after the injury (up to 24 hours); or alteration in mental state at the time of the injury (becoming dazed or confused).
- Has current complaints of TBI symptoms such as headache, dizziness, or cognitive or affective problems that score at least 3 post-concussive symptoms as assessed by the OSU TBI-ID.
- Has received current standard of care pharmacologic and nonpharmacologic interventions for TBI and any concomitant PTSD w/ no significant change in psychoactive therapy for at least 1 month

Exclusion Criteria:

Prisoners.
Pregnant Women.
Minors.
Individuals whose most recent TBI was sustained during illegal activity.
Potential participants stationed >1 hour outside the designated recruitment area will be excluded unless the command authorizes temporary relocation and appropriate relocation resources.
Active duty individuals with anticipated prolonged TAD/TDY, administrative separation, or deployment within 6 months of study enrollment will be excluded.
- An individual with any of the following characteristics will be excluded from this study based on contraindications to hyperbaric pressurization and hyperbaric oxygenation or other study assessment measures:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611194

Contacts

Contact: Susan Churchill, APRN, NP	1-877-445-3199	susan.churchill@imail.org
Contact: Lindell Weaver, MD,FACP, UHM	801-408-3623	Lindell.Weaver@imail.org

Locations

United States, Colorado
Outcomes Assessment Center, Evans Army Community Hospital	Recruiting
Colorado Springs, Colorado, United States, 80913
Contact: Susan Churchill, APRN, NP 877-445-3199 susan.churchill@imail.org
Contact: Robert C. Price, MD 719.524.2221 robert.c.price@amedd.army.mil
Principal Investigator: Robert C Price, md
Evans Army Community Hospital / Hyperbaric Medicine Complex	Recruiting
Ft Carson, Colorado, United States, 80913
Contact: Susan Churchill, APRN, NP 877-445-3199 susan.churchill@imail.org
Contact: Robert C Price, MD 719.524.2221 robert.c.price@amedd.army.mil
Principal Investigator: Robert C Price, MD
United States, Washington
TBI Program/HBO2 Research Program Madigan Healthcare system	Recruiting
Tacoma, Washington, United States, 98431
Contact: Susan Churchill, APRN, NP 877-445-3199 susan.churchill@imail.org
Contact: Paul J Savage, MD 253.968.0606 paul.j.savage@us.army.mil
Principal Investigator: Paul J Savage, MD

Sponsors and Collaborators

U.S. Army Medical Research and Materiel Command

Investigators

Principal Investigator:

Lindell Weaver, MD

Intermountain Health Care, Inc.

More Information

No publications provided

Responsible Party:	U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:	NCT01611194 History of Changes
Other Study ID Numbers:	S-11-17
Study First Received:	May 3, 2012
Last Updated:	October 1, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:

HBO2
HBOT
mTBI
Brain injury

PCS
PTSD
hyperbaric oxygen

Additional relevant MeSH terms:

Unconsciousness
Brain Injuries
Post-Concussion Syndrome
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

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

ClinicalTrials.gov processed this record on May 16, 2013

mTBI Mechanisms of Action of HBO2 for Persistent Post-Concussive Symptoms (BIMA)