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Deep Brain Stimulation for Traumatic Brain Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01277952
First received: January 13, 2011
Last updated: March 28, 2017
Last verified: March 2017
January 13, 2011
March 28, 2017
January 2011
September 2016   (Final data collection date for primary outcome measure)
Improvement in Brain Functioning [ Time Frame: 16 months ]
Brain functioning improvement in functional independence, community participation and subjective well-being.
Same as current
Complete list of historical versions of study NCT01277952 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Deep Brain Stimulation for Traumatic Brain Injury
Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Traumatic Brain Injury
Device: Deep Brain Stimulation
Brain pace maker, implanted in the brain
Other Name: DBS
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.
Intervention: Device: Deep Brain Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
September 2016
September 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01277952
2010H0264
Yes
Not Provided
Plan to Share IPD: No
Ali Rezai, MD, The Ohio State University
Ali Rezai, MD
Not Provided
Principal Investigator: Ali Rezai, M.D. Ohio State University
Ohio State University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP