Overview

This trial is active, not recruiting.

Condition traumatic brain injury
Treatment deep brain stimulation
Sponsor Ali Rezai, MD
Start date January 2011
End date August 2016
Trial size 5 participants
Trial identifier NCT01277952, 2010H0264

Summary

The study will evaluate the benefit of Deep Brain Stimulation for subjects with severe disability due to Traumatic Brain Injury.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
deep brain stimulation DBS
Brain pace maker, implanted in the brain

Primary Outcomes

Measure
Improvement in Brain Functioning
time frame: 16 months

Eligibility Criteria

Male or female 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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Ohio State University.