Deep Brain Stimulation for Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Device: Deep Brain Stimulation

• 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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-17
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DBS Surgery	Deep Brain Stimulation	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.

Primary Outcome Measures

Name	Time	Method
Improvement in Brain Functioning	16 months	Brain functioning improvement in functional independence, community participation and subjective well-being.

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States