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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835443
• Other study ID #: REDD 0002
• Status: Completed
• Phase: N/A
• Start date: October 26, 2016
• Est. completion date: January 2023

Study information

• Verified date: October 2023
• Source: Enspire DBS Therapy, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2023
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Ischemic Stroke
• Paresis
• Stroke

Intervention

Device:
• Deep Brain Stimulation
Electrical stimulation of the dentate nucleus area of the cerebellum.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Enspire DBS Therapy, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	Incidence of study-related serious adverse events	18 Months