Deep Brain Stimulation for Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:

Deep Brain Stimulation for Treatment of Severe Disability From Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01277952
• Other study ID #: 2010H0264
• Status: Completed
• Phase: N/A
• First received: January 13, 2011
• Last updated: March 28, 2017
• Start date: January 2011
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Device:
• Deep Brain Stimulation
Brain pace maker, implanted in the brain

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ali Rezai, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Brain Functioning	Brain functioning improvement in functional independence, community participation and subjective well-being.	16 months