Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, DBS
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.
Interventions
DEVICEDeep Brain Stimulation
Brain pace maker, implanted in the brain
Sponsors
Ali Rezai, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Brain Functioning | 16 months | Brain functioning improvement in functional independence, community participation and subjective well-being. |
Countries
United States
Outcome results
None listed