Deep Brain Stimulation for Traumatic Brain Injury
This trial has been completed.
|Condition||traumatic brain injury|
|Treatment||deep brain stimulation|
|Sponsor||Ali Rezai, MD|
|Start date||January 2011|
|End date||September 2016|
|Trial size||4 participants|
|Trial identifier||NCT01277952, 2010H0264|
The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury.
|Intervention model||single group assignment|
Improvement in Brain Functioning
time frame: 16 months
All participants from 20 years up to 60 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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
|Official title||Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury|
|Principal investigator||Ali Rezai, M.D.|
|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.|
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