EDEN: Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke
Study Details
Study Description
Brief Summary
This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment of stroke and will help understand if DBS improves motor recovery for patients who continue to have significant impairment.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Detailed Description
The proposed study is a safety and feasibility study intended to provide preliminary data to design a future pilot study. The objective of this study is to document the safety and patient outcomes of electrical stimulation of the dentate nucleus area for the management of chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Electrical Stimulation This is a single arm study and all subjects will receive electrical stimulation. |
Device: Deep Brain Stimulation
Electrical stimulation of the dentate nucleus area of the cerebellum.
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Outcome Measures
Primary Outcome Measures
- Adverse Events [18 Months]
Incidence of all serious adverse events
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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One-time stroke that occurred 1-3 years ago (i.e. index stroke 12-36 months)
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Stroke due to a blocked blood vessel (i.e. unilateral MCA stroke)
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Moderate to severe weakness in one arm (i.e. unilateral upper-extremity hemiparesis)
Key Exclusion Criteria:
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Seizures since time of stroke (i.e. seizures or seizure disorder)
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Unable to have an MRI (i.e. contraindicated for MRI)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
Sponsors and Collaborators
- Enspire DBS Therapy, Inc.
Investigators
- Principal Investigator: Andre Machado, MD, PhD, The Cleveland Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REDD 0002