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Clinical Trials/NCT01277952
NCT01277952
Completed
Not Applicable

Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury

Ali Rezai, MD1 site in 1 country4 target enrollmentJanuary 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Ali Rezai, MD
Enrollment
4
Locations
1
Primary Endpoint
Improvement in Brain Functioning
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
September 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Ali Rezai, MD
Responsible Party
Sponsor Investigator
Principal Investigator

Ali Rezai, MD

MD

Ohio State University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Improvement in Brain Functioning

Time Frame: 16 months

Brain functioning improvement in functional independence, community participation and subjective well-being.

Study Sites (1)

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