DBS – Upper Extremity Function
Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke (EDEN)
EDEN is a Phase I clinical trial of deep brain stimulation (DBS) therapy for stroke recovery, sponsored by Enspire DBS Therapy, Inc. Enspire, in partnership with Cleveland Clinic and Boston Scientific, is developing a proprietary DBS therapy to restore motor function for stroke survivors living with disability. Enspire plans to revitalize stroke recovery by using DBS, alongside physical rehabilitation, to restore motor function for hemiplegic stroke patients. By stimulating the pathways from the cerebellum, DBS therapy can enhance the effects of rehabilitation for post-stroke recovery. Unlike cortical stimulation and noninvasive therapies, Enspire’s therapy relies on a robust natural pathway to mediate the effects of stimulation and physical therapy.
About This Study
Objective/Specific Aims: 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.
Study Information: 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.
To learn more about Enspire DBS Therapy, follow this link
Detailed program information and criteria available at: https://clinicaltrials.gov/ct2/show/NCT02835443
|Principal Investigators:||Andre Machado, MD, PhD|