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Deep Brain Stimulation for Traumatic Brain Injury

Primary Purpose

Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Ali Rezai, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, DBS

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DBS Surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 13, 2011
Last Updated
March 28, 2017
Sponsor
Ali Rezai, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01277952
Brief Title
Deep Brain Stimulation for Traumatic Brain Injury
Official Title
Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ali Rezai, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, DBS

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DBS Surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Other Intervention Name(s)
DBS
Intervention Description
Brain pace maker, implanted in the brain
Primary Outcome Measure Information:
Title
Improvement in Brain Functioning
Description
Brain functioning improvement in functional independence, community participation and subjective well-being.
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Rezai, M.D.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Deep Brain Stimulation for Traumatic Brain Injury

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