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

NCT00715052 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-05-07

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Hyperbaric Oxygen Therapy (HBOT)

40 consecutive one hour treatments at 1.5 ATA with 100% O2

Sponsors & Collaborators

  • Assaf-Harofeh Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2012-06-30

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00715052 on ClinicalTrials.gov