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

Enspire DBS Therapy, Inc.12 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Deep Brain StimulationDEVICE

Electrical stimulation of the dentate nucleus area of the cerebellum.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

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)

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Adverse Events

Incidence of study-related serious adverse events

Time frame: 18 Months

Data from ClinicalTrials.gov

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