IRB Study Number 22-1111
Status Recruiting
Phase Phase 2
Location Cleveland Clinic Main Campus
Institute Neurological Institute
Description
Purpose of this study:
- This clinical trial is to learn if deep brain stimulation plus rehab therapy (DBS +Rehab) improves arm mobility for patients who had a stroke and continue to have impairment. Study treatment may improve functioning in the arm.
Participation:
- Study participation is about 1.5 years
Study-related activities:
- Participants will undergo a surgical procedure for deep brain stimulation (DBS)
- Five months of rehab therapy will follow a month after surgery
- Assessments and imaging (CT and MRI scans) occur throughout the study at Main Campus facilities
Compensation:
- All study-related activities (including assessments and surgery) and transportation will be provided. Participants will be paid for completed visits (or sets of visits) as compensation for their participation throughout the course of the study.
Inclusion Criteria
- 22 years of age or older
- Suffered a stroke in past 1-6 years
- Moderate to severe arm weakness and impaired function
- Ability to move some fingers, thumb, or wrist
Exclusion Criteria
- Unable to provide written consent, adequately communicate, or complete questionnaires on own
- Diagnosis of progressive neurological disease such as multiple sclerosis or Alzheimer's
- Diagnosis of epilepsy
- Chronic uncontrolled high blood pressure
- History of severe cardiovascular disease
- Having implantable device such as pacemaker
