Deep Brain Stimulation for Traumatic Brain Injury
The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury|
- Improvement in Brain Functioning [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]Brain functioning improvement in functional independence, community participation and subjective well-being.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: DBS Surgery
Deep brain stimulation (DBS) will be the treatment option in this study along with behavioral interventions for participants with severe disability due to Traumatic Brain Injury (TBI) 24 months post their injury, the participants will have severe disabilities in behavioral and emotional self-regulation, cognitive impairments and somatic symptoms.
Device: Deep Brain Stimulation
Brain pace maker, implanted in the brain
Other Name: DBS
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277952
|United States, Ohio|
|The Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Ali Rezai, M.D.||Ohio State University|