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

Enspire DBS Therapy

Status: Completed

Conditions: Stroke

Treatments: Device: Deep Brain Stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT02835443

REDD 0002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Electrical Stimulation

Experimental group

Description:

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

Treatment:

Device: Deep Brain Stimulation