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

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ClinicalTrials.gov Identifier: NCT00715052
Recruitment Status : Completed
First Posted : July 15, 2008
Last Update Posted : May 7, 2013
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Study Description
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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 Design
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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

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Arms and Interventions
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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


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

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

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00715052


Locations
Israel
Research & Development unit, Asaf-Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shai Efrati, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00715052     History of Changes
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:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System