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The Effect of Hyperbaric Oxygen Therapy on Patients Suffering From Neurologic Deficiency Due Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00715052
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : May 7, 2013
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

Traumatic brain injuries (TBI) are a major cause of morbidity and mortality worldwide. Due to improvements in emergency medical care, transportation and specialized trauma facilities, the number of people surviving TBI with impairment has significantly increased in recent years. The long term cognitive sequelae, which are often not visible persist far beyond the resolution of the obvious physical disabilities. This combined with the relatively low awareness of the general public has designated TBI as the "silent epidemic" (TBI CDC 2006). Hyperbaric oxygen therapy (HBOT) has been suggested as a possible treatment modality for these cases and preliminary studies are promising.

The purpose of this study is to evaluate the effectiveness of HBOT in the treatment of chronic mild traumatic brain injuries (mTBI). Sequential SPECT scans of the brain and neurocognitive testing will be used to evaluate cerebral blood flow (CBF) response, cognitive and functional improvement following treatment.

Condition or disease Intervention/treatment Phase
Neurologic Deficiency Traumatic Brain Injury Procedure: Hyperbaric Oxygen Therapy (HBOT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : August 2008
Actual Primary Completion Date : June 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
40 consecutive one hour treatments at 1.5 ATA with 100% O2
Procedure: Hyperbaric Oxygen Therapy (HBOT)
40 consecutive one hour treatments at 1.5 ATA with 100% O2

No Intervention: 2

Primary Outcome Measures :
  1. Neurologic evaluation [ Time Frame: 2 and 4 months ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • TBI patients age 16 or older who are at least one year post injury with stable cognitive deficits will be recruited

Exclusion Criteria:

  • Had been treated with HBOT for any indiction prior to their inclusion.
  • Have any other indication for HBOT
  • Chest pathology incompatible with pressure changes
  • Inner ear disease
  • Patients suffering from claustrophobia.
  • Inability to give written informed consent by the patient or his trustee.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00715052

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Research & Development unit, Asaf-Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Shai Efrati, Assaf-Harofeh Medical Center Identifier: NCT00715052    
Other Study ID Numbers: HBOtbi1
First Posted: July 15, 2008    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: October 2008
Keywords provided by Assaf-Harofeh Medical Center:
neurologic deficiency due traumatic brain injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System