NCT02835443

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

Electrical Stimulation of the Dentate Nucleus Area (EDEN) for Improvement of Upper Extremity Hemiparesis Due to Ischemic Stroke: A Safety and Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Enspire DBS Therapy, Inc. · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	Electrical stimulation of the dentate nucleus area of the cerebellum.

Timeline

• Start date: 2016-10-26
• Primary completion: 2021-07-01
• Completion: 2023-01-01
• First posted: 2016-07-18
• Last updated: 2023-10-13
• Results posted: 2023-10-05

Locations

1 site across 1 country: United States