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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Deep Brain Stimulation Device
    Intervention Desc: Electrical stimulation of the dentate nucleus area of the cerebellum.
    ARM 1: Kind: Experimental
    Label: Electrical Stimulation
    Description: This is a single arm study and all subjects will receive electrical stimulation .

Trial Design

  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Adverse Events 18 Months Yes

Sponsors