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

This study has been completed.
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00715052
First received: July 14, 2008
Last updated: May 6, 2013
Last verified: October 2008
History of Changes
  Purpose

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 Intervention
Neurologic Deficiency
Traumatic Brain Injury
 Procedure: Hyperbaric Oxygen Therapy (HBOT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Neurologic evaluation [ Time Frame: 2 and 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: August 2008
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00715052

Locations
Israel
Research & Development unit, Asaf-Harofeh Medical Center
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
  More Information

No publications provided

Responsible Party: Shai Efrati, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT00715052     History of Changes
Other Study ID Numbers: HBOtbi1
Study First Received: July 14, 2008
Last Updated: May 6, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Assaf-Harofeh Medical Center:
neurologic deficiency due traumatic brain injury

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on June 13, 2013