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

October 9, 2023 updated by: Enspire DBS Therapy, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 18 Months
Incidence of study-related serious adverse events
18 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enspire DBS Therapy, Inc.

Investigators

  • Principal Investigator: Andre Machado, MD, PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2016

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

July 7, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimated)

July 18, 2016

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REDD 0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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