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
|
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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 |

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 |
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 |
- Neurologic evaluation [ Time Frame: 2 and 4 months ]

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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.

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
Israel | |
Research & Development unit, Asaf-Harofeh Medical Center | |
Zerifin, Israel, 70300 |
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 |