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Completed

NCT Number: NCT02835443

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

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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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Vascular Diseases

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Deep brain stimulation

Device

Electrical stimulation of the dentate nucleus area of the cerebellum.

Primary outcomes

  1. Adverse Events

    Time frame: 18 Months

    Incidence of study-related serious adverse events

Sponsors and collaborators

Lead sponsor

Enspire DBS Therapy, Inc.

Industry

Registry information

Official study title

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

Acronym: EDEN

Important dates

Study start
2016
Primary completion
2021
Study completion
2023
First posted
Jul 18, 2016
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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