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Trial record 7 of 10 for:    Cleveland clinic, DBS

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

This study is currently recruiting participants.
Verified October 2017 by Enspire DBS Therapy, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02835443
First Posted: July 18, 2016
Last Update Posted: October 12, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Enspire DBS Therapy, Inc.
  Purpose
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 Intervention
Stroke Device: Deep Brain Stimulation

Study Type: Interventional
Study Design: 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

Further study details as provided by Enspire DBS Therapy, Inc.:

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


Estimated Enrollment: 12
Study Start Date: June 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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


Contacts
Contact: Alexandria Wyant 216-444-1179 wyanta@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alexandria Wyant    216-444-1179    wyanta@ccf.org   
Principal Investigator: Andre Machado, MD, PhD         
Sponsors and Collaborators
Enspire DBS Therapy, Inc.
Investigators
Principal Investigator: Andre Machado, MD, PhD The Cleveland Clinic
  More Information

Responsible Party: Enspire DBS Therapy, Inc.
ClinicalTrials.gov Identifier: NCT02835443     History of Changes
Other Study ID Numbers: REDD 0002
First Submitted: July 7, 2016
First Posted: July 18, 2016
Last Update Posted: October 12, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Enspire DBS Therapy, Inc.:
Ischemic Stroke
Deep Brain Stimulation
DBS
Physical Therapy
Rehab
Brain Stimulation

Additional relevant MeSH terms:
Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms