Deep Brain Stimulation for Traumatic Brain Injury
This study is currently recruiting participants.
Verified May 2013 by Ohio State University
Sponsor:
Ali Rezai, MD
Information provided by (Responsible Party):
Ali Rezai, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01277952
First received: January 13, 2011
Last updated: May 14, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01277952
Contacts
| Contact: Phuong Nguyen | 6143666952 | phuong.nguyen2@osumc.edu |
Locations
| United States, Ohio | |
| The Ohio State University Medical Center | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| Contact: Phuong Nguyen 614-366-6952 phuong.nguyen2@osumc.edu | |
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: | 2010H0264 |
| Study First Received: | January 13, 2011 |
| Last Updated: | May 14, 2013 |
| 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 Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013