Hyperbaric Oxygen for Civilian Post-concussive Syndrome (HYBOBI2)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by Intermountain Health Care, Inc.
Sponsor:
Collaborator:
Brigham Young University
Information provided by (Responsible Party):
Lindell Weaver, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01986205
First received: October 31, 2013
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after concussion. This study will enroll 90 individuals with persistent problems 1-5 years after a mild traumatic brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions.

Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 12 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research.


Condition Intervention Phase
Post-concussion Syndrome
Drug: Hyperbaric Oxygen
Drug: Pressurized Air (1.2)
Drug: Pressurized Air (1.0)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Trial of Hyperbaric Oxygen Versus Sham in Civilian Post-concussive Syndrome

Resource links provided by NLM:


Further study details as provided by Intermountain Health Care, Inc.:

Primary Outcome Measures:
  • Neurobehavioral Symptom Inventory [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurobehavioral Symptom Inventory [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Incidence of myopia [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: January 2014
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperbaric Oxygen
100% oxygen at 1.5 atmospheres absolute for 60 minutes, 40 sessions
Drug: Hyperbaric Oxygen
Other Names:
  • HBO2
  • HBOT
  • HBO
  • Hyperbaric oxygen therapy
Sham Comparator: Pressurized Air (1.2)
Regular air at 1.2 atmospheres absolute for 60 minutes, 40 sessions
Drug: Pressurized Air (1.2)
Placebo Comparator: Pressurized Air (1.0)
Regular air at 1.0 atmospheres absolute for 60 minutes, 40 sessions
Drug: Pressurized Air (1.0)
Other Name: Sea level air

Detailed Description:

This is a single center, randomized, double-blind study to explore whether a course of hyperbaric oxygen can ameliorate persistent post-concussive symptoms after mild traumatic brain injury. In this study, civilian adult men and women with persistent symptoms 1 to 5 years after injury will be randomized to receive 40 hyperbaric oxygen sessions (100% oxygen at 1.5 atmospheres absolute for 60 minutes) or sham chamber sessions (room air at 1.2 atmospheres absolute or room air at sea level pressure, for 60 minutes). Chamber sessions will be provided Monday through Friday, excluding holidays, and participants will have up to 12 weeks to complete their 40 sessions.

Participants will be evaluated before the chamber sessions, at 13 weeks, and at 12 months. Assessments include self-administered questionnaires, neuropsychological function, neuroimaging, a brief neurological examination, and a neuro-optometry evaluation. These outcome tools will measure symptoms and deficit at the time of enrollment and subsequent evaluations, and provide insight into whether hyperbaric oxygen can play a role in recovery from mild traumatic brain in-jury.

Participants will be asked to provide blood for long-term storage of serum, plasma, and DNA for future investigations.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults, age 18-60, both men and women
  • Able to speak and read English as primary language
  • Able and willing to provide written informed consent for study participation.
  • Able and willing to complete outcome assessments and provide blood and urine samples as required by the study protocol.
  • Able to tolerate the chamber environment and hood placement and to equalize middle ear pressure.
  • Past history of at least one mild traumatic brain injury with persistent symptoms that meets all of the following criteria: 1) Brain injury occurred at least 1 year but no more than 5 years prior to enrollment; 2) Brain injury occurred as an adult (at least 18 years of age); and, 3) Brain injury occurred due to non-penetrating trauma and is graded as mild.
  • At least 3 of the following persistent post-concussive symptoms from the injury: headaches, dizziness or balance problems, blurred vision, tiredness/fatigue or sleep problems, seizures, remembering things or solving problems, managing stress or emotional upsets, controlling temper/irritability, or ringing in the ears.

Exclusion Criteria:

  • Diabetes mellitus.
  • Uncontrolled seizure disorder (participants must be on therapy and seizure-free for at least 6 months).
  • Claustrophobia precluding chamber or hood tolerance.
  • Implanted devices not cleared for hyperbaric pressurization.
  • Pregnancy or plans to become pregnant during the study participation period. Women of childbearing potential will be asked to use an acceptable form of birth control through the 13-week assessment visit.
  • Lung disease, such as emphysema, chronic bronchitis, asthma that is not well-controlled, or bullous lung disease, that raises the risk for pulmonary barotrauma due to air trapping.
  • Active malignancy, previous malignancy (except basal cell carcinoma) in the last 5 years, or any prior treatment with bleomycin (Blenoxane). Prior treatment with doxorubicin (Adriamycin) is acceptable as long follow-up echocardiography is normal.
  • Chronic disease such as heart or renal failure would raise the participant's risk of adverse events during hyperbaric oxygenation.
  • Prior military service in theater.
  • Alcohol abuse, by self-report, within the last year.
  • Lifetime history of illicit drug use, by self-report, except remote (greater than one year), non-habitual use of marijuana.
  • Failed urine drug screen during study participation.
  • Continued participation during the intervention period in sports activities where head injury is likely, such as contact football, boxing, mixed martial arts, etc.
  • Blind or deaf.
  • Major psychiatric disorder or degenerative mental disease (such as multiple sclerosis).
  • Prior therapeutic radiation to the central nervous system.
  • Prior traumatic brain injury meeting severe or moderate classification, or any anoxic injury or stroke.
  • Known untreated chronic or acute medical conditions, such as hypothyroidism, Cushing's disease, untreated hypertension, etc., that would confound the outcome assessments or inhibit compliance with the study protocol. If treated, these disorders would not be excluded.
  • Prior hyperbaric oxygen for brain injury.
  • Prior hyperbaric oxygen for any reason within the last 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01986205

Contacts
Contact: Susan Churchill, APRN-NP 801-408-3623 susan.churchill@imail.org

Locations
United States, Utah
Intermountain Medical Center Not yet recruiting
Murray, Utah, United States, 84157
Contact: Susan Churchill, APRN-NP    801-408-3623    susan.churchill@imail.org   
Principal Investigator: Lindell K. Weaver, MD         
Sponsors and Collaborators
Lindell Weaver
Brigham Young University
Investigators
Principal Investigator: Lindell K. Weaver, MD Intermountain Health Care, Inc.
  More Information

Publications:
Responsible Party: Lindell Weaver, Medical Director, Hyperbaric Medicine, Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01986205     History of Changes
Other Study ID Numbers: 1024845
Study First Received: October 31, 2013
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Intermountain Health Care, Inc.:
Concussion, mild
Traumatic brain injury
Hyperbaric oxygenation
Post-concussion symptoms
Headache

Additional relevant MeSH terms:
Brain Concussion
Post-Concussion Syndrome
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating

ClinicalTrials.gov processed this record on July 23, 2014