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

Sponsor
Enspire DBS Therapy, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02835443
Collaborator
(none)
12
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1
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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
  • Device: Deep Brain Stimulation
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

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Oct 26, 2016
Actual Primary Completion Date :
Jul 1, 2021
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Adverse Events [18 Months]

    Incidence of all serious adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Enspire DBS Therapy, Inc.
ClinicalTrials.gov Identifier:
NCT02835443
Other Study ID Numbers:
  • REDD 0002
First Posted:
Jul 18, 2016
Last Update Posted:
Aug 2, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Enspire DBS Therapy, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022