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Deep Brain Stimulation for Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT01277952
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : March 30, 2017
Information provided by (Responsible Party):
Ali Rezai, MD, Ohio State University

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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Deep Brain Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury
Study Start Date : January 2011
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: DBS Surgery
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.
Device: Deep Brain Stimulation
Brain pace maker, implanted in the brain
Other Name: DBS

Primary Outcome Measures :
  1. Improvement in Brain Functioning [ Time Frame: 16 months ]
    Brain functioning improvement in functional independence, community participation and subjective well-being.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01277952

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United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ali Rezai, MD
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Principal Investigator: Ali Rezai, M.D. Ohio State University
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Responsible Party: Ali Rezai, MD, MD, Ohio State University
ClinicalTrials.gov Identifier: NCT01277952    
Other Study ID Numbers: 2010H0264
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ali Rezai, MD, Ohio State University:
Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System