Deep Brain Stimulation for Traumatic Brain Injury
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT01277952
- Lead Sponsor
- Ali Rezai, MD
- Brief Summary
The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury.
- Detailed Description
The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury. DBS has been proven safe and efficacious for remediation of multiple neurological conditions. It is the hope of the study team that the protocol will provide further insight into the potential of DBS to improve the quality of life and functioning of persons with severe disability due to TBI and at the same time can provide new clinical insights that will improve treatment for the entire spectrum of injury severity.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
- 24 months post traumatic brain injury Scores in Severe range of the Glasgow Outcome Scale-Extended Evidence of impaired cognitive functioning Medically and neurologically stable
- Medical contraindications for surgery Evidence of substance abuse in the last 12 months Current Diagnosis of major depressive disorder current participation in rehabilitation services Co-morbid conditions that would interfere with study activities
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improvement in Brain Functioning 16 months Brain functioning improvement in functional independence, community participation and subjective well-being.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
The Ohio State University Medical Center🇺🇸Columbus, Ohio, United States