Deep Brain Stimulation for Traumatic Brain Injury

Ali Rezai, MD4 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Traumatic Brain Injury

Interventions

Deep Brain StimulationDEVICE

Brain pace maker, implanted in the brain

Eligibility

Sex: ALLMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Improvement in Brain Functioning

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

Time frame: 16 months

Data from ClinicalTrials.gov

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