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NCT02835443 Clinical Trial

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

Stroke Clinical Trial

— EDEN  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02835443
Other study ID # REDD 0002
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 26, 2016
Est. completion date January 2023

Study information
Verified date October 2023
Source Enspire DBS Therapy, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date January 2023
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 75 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Deep Brain Stimulation
Electrical stimulation of the dentate nucleus area of the cerebellum.

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)
Lead Sponsor Collaborator
Enspire DBS Therapy, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events Incidence of study-related serious adverse events 18 Months
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