Back to resultsElectrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke (EDEN)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehab, Brain Stimulation
Eligibility 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)
Sites / Locations
- Cleveland Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electrical Stimulation
Arm Description
This is a single arm study and all subjects will receive electrical stimulation.
Outcomes
Primary Outcome Measures
Adverse Events
Incidence of study-related serious adverse events
Secondary Outcome Measures
Full Information
NCT ID
NCT02835443
First Posted
July 7, 2016
Last Updated
October 9, 2023
Sponsor
Enspire DBS Therapy, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02835443
Brief Title
Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke
Acronym
EDEN
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 26, 2016 (Actual)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
January 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enspire DBS Therapy, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Ischemic Stroke, Deep Brain Stimulation, DBS, Physical Therapy, Rehab, Brain Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electrical Stimulation
Arm Type
Experimental
Arm Description
This is a single arm study and all subjects will receive electrical stimulation.
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Intervention Description
Electrical stimulation of the dentate nucleus area of the cerebellum.
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of study-related serious adverse events
Time Frame
18 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre Machado, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke
We'll reach out to this number within 24 hrs