Deep Brain Stimulation for Traumatic Brain Injury

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01277952
First received: January 13, 2011
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Traumatic Brain Injury
Device: Deep Brain Stimulation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Improvement in Brain Functioning [ Time Frame: 16 months ] [ Designated as safety issue: Yes ]
    Brain functioning improvement in functional independence, community participation and subjective well-being.


Estimated Enrollment: 5
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277952

Locations
United States, Ohio
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ali Rezai, MD
Investigators
Principal Investigator: Ali Rezai, M.D. Ohio State University
  More Information

No publications provided

Responsible Party: Ali Rezai, MD, MD, The Ohio State University
ClinicalTrials.gov Identifier: NCT01277952     History of Changes
Other Study ID Numbers: DBS for TBI, 2010H0264
Study First Received: January 13, 2011
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University:
Traumatic Brain Injury
DBS

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014