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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-26

Study Completion Date

2023-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Electrical Stimulation

This is a single arm study and all subjects will receive electrical stimulation.

Group Type EXPERIMENTAL

Deep Brain Stimulation

Intervention Type DEVICE

Electrical stimulation of the dentate nucleus area of the cerebellum.

Interventions

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Deep Brain Stimulation

Electrical stimulation of the dentate nucleus area of the cerebellum.

Intervention Type DEVICE

Eligibility Criteria

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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)