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

Enspire DBS Therapy, Inc.1 site in 1 country12 target enrollmentOctober 26, 2016

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: Enspire DBS Therapy, Inc.
Enrollment: 12
Locations: 1
Primary Endpoint: Adverse Events
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

October 26, 2016

End Date

January 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Enspire DBS Therapy, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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)