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

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT02835443
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-13
• Study First Posted: 2016-07-18
• Study Start: 2016-10-26
• Primary Completion: 2021-07
• Study Completion: 2023-01
• Results First Submitted: 2023-09-08
• Results First Submitted QC: 2023-09-08
• Status Verified: 2023-10
• Results First Posted: 2023-10-05
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Adverse Events	18 Months	Incidence of study-related serious adverse events

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States