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The Effect of Hyperbaric Oxygen Therapy on Patients Suffering From Neurologic Deficiency Due Traumatic Brain Injury
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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 Intervention Model: Crossover Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
- Neurologic evaluation [ Time Frame: 2 and 4 months ]
| 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 (Child, Adult, Senior) |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00715052
| Israel | |
| Research & Development unit, Asaf-Harofeh Medical Center | |
| Zerifin, Israel, 70300 | |
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 |
| Study First Received: | July 14, 2008 |
| Last Updated: | May 6, 2013 |
Keywords provided by Assaf-Harofeh Medical Center:
|
neurologic deficiency due traumatic brain injury |
Additional relevant MeSH terms:
|
Wounds and Injuries Brain Injuries Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System |
ClinicalTrials.gov processed this record on September 21, 2017