The Effect of Hyperbaric Oxygen Therapy on Patients Suffering From Neurologic Deficiency Due Traumatic Brain Injury
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2008
CompletedFirst Posted
Study publicly available on registry
July 15, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedMay 7, 2013
October 1, 2008
3.8 years
July 14, 2008
May 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurologic evaluation
2 and 4 months
Study Arms (2)
1
EXPERIMENTAL40 consecutive one hour treatments at 1.5 ATA with 100% O2
2
NO INTERVENTIONInterventions
40 consecutive one hour treatments at 1.5 ATA with 100% O2
Eligibility Criteria
You may qualify if:
- TBI patients age 16 or older who are at least one year post injury with stable cognitive deficits will be recruited
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research & Development unit, Asaf-Harofeh Medical Center
Ẕerifin, 70300, Israel
Related Publications (1)
Boussi-Gross R, Golan H, Fishlev G, Bechor Y, Volkov O, Bergan J, Friedman M, Hoofien D, Shlamkovitch N, Ben-Jacob E, Efrati S. Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial. PLoS One. 2013 Nov 15;8(11):e79995. doi: 10.1371/journal.pone.0079995. eCollection 2013.
PMID: 24260334DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 14, 2008
First Posted
July 15, 2008
Study Start
August 1, 2008
Primary Completion
June 1, 2012
Last Updated
May 7, 2013
Record last verified: 2008-10