Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke



Status:Recruiting
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:25 - 75
Updated:2/10/2019
Start Date:June 2016
End Date:July 2021
Contact:Alexandria Wyant
Email:wyanta@ccf.org
Phone:216-444-1179

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Trial Summary
Trial Overview
Inclusion Criteria

Electrical Stimulation of the Dentate Nucleus Area (EDEN) for Improvement of Upper Extremity Hemiparesis Due to Ischemic Stroke: A Safety and Feasibility Study

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.

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.

Key Inclusion Criteria:

- One-time stroke that occurred 1-3 years ago (i.e. index stroke 12-36 months)

- Stroke due to a blocked blood vessel (i.e. unilateral MCA stroke)

- Moderate to severe weakness in one arm (i.e. unilateral upper-extremity hemiparesis)

Key Exclusion Criteria:

- Seizures since time of stroke (i.e. seizures or seizure disorder)

- Unable to have an MRI (i.e. contraindicated for MRI)
We found this trial at
1
site
Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Andre Machado, MD, PhD
Phone: 216-444-1179
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