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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02835443
Recruitment Status : Active, not recruiting
First Posted : July 18, 2016
Last Update Posted : August 2, 2022
Information provided by (Responsible Party):
Enspire DBS Therapy, Inc.

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
Stroke Device: Deep Brain Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 26, 2016
Actual Primary Completion Date : July 2021
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

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.

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 18 Months ]
    Incidence of all serious adverse events

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02835443

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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Enspire DBS Therapy, Inc.
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Principal Investigator: Andre Machado, MD, PhD The Cleveland Clinic
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Responsible Party: Enspire DBS Therapy, Inc.
ClinicalTrials.gov Identifier: NCT02835443    
Other Study ID Numbers: REDD 0002
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Enspire DBS Therapy, Inc.:
Ischemic Stroke
Deep Brain Stimulation
Physical Therapy
Brain Stimulation
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations