Enspire DBS Therapy Announces the Publication of EDEN, an Early Feasibility Trial of Deep Brain Stimulation (DBS) plus Rehab for Stroke Patients, in Nature Medicine

• Study participants showed meaningful improvements in both motor impairment and function

CLEVELAND, Aug. 15, 2023 /PRNewswire/ -- Enspire DBS Therapy, Inc., (Enspire) a clinical stage company developing an implantable neuromodulation therapy for post-stroke recovery, announced today the publication of the results of The EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke), an early feasibility study led by Cleveland Clinic researchers, in Nature Medicine.

The EDEN study was designed to evaluate whether DBS plus rehabilitation therapy (DBS+Rehab) would improve motor function in patients post Ischemic Stroke more effectively than rehab alone. The study demonstrated that the majority of participants (9 out of 12) showed the most significant improvements in both motor impairment and function during the combination therapy, DBS+Rehab. Importantly, participants with at least minimal preservation of distal motor function at enrollment showed clinically significant gains.  The safety profile of this therapy is similar to other approved DBS therapies.

These findings build on more than a decade of preclinical work led by principal investigators Andre Machado, M.D., Ph.D., and Kenneth Baker, Ph.D., at Cleveland Clinic.  Dr. Machado patented the DBS method in stroke recovery to which Enspire has an exclusive license.   Dr. Machado holds stock options and equity ownership rights with Enspire and serves as the Chief Scientific Officer.

"We saw patients in the study regain levels of function and independence they did not have before enrolling in the research," Dr. Machado said. "We look forward to expanding as we have begun the next phase of clinical investigation."

Enspire has launched RESTORE, a pivotal study continuing to investigate the safety and effectiveness of DBS+Rehab on patients with chronic upper extremity impairment due to stroke.  The study has received IDE approval from the FDA and is actively recruiting patients. 

About Stroke
Approximately 800,000 people in the United States alone suffer strokes every year and is the leading cause of long-term disabilities. While the majority of patients will survive the acute phase, persistent neurological issues will likely jeopardize quality of life and productivity, with approximately 50% of survivors still exhibiting disability severities that require assistance with daily activities.

About EDEN
The EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke) conducted at Cleveland Clinic, enrolled 12 individuals with chronic, moderate-to-severe hemiparesis of the upper extremity as a result of a unilateral middle cerebral artery stroke 1-3 years prior.

Each participant was implanted with a DBS System, which involved the surgical implantation of electrodes into the cerebellum.  Following discharge and recovery from the surgery, participants completed several months of physical therapy, first with the DBS device turned off for several weeks and then turned on for four-to-eight months.

About RESTORE
The RESTORE Stroke Pivotal Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke to support marketing approval of this therapy.

Each participant will be implanted with a commercially available third-party DBS system and receive a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, participants assigned to active-control treatment (Ct) (rehab only) will cross over to receive DBS treatment (Tt) and participate in a second five-month therapy program. For more information see ClinicalTrials.gov ID NCT05701280.  The RESTORE trial is actively recruiting.  www.restorestrokestudy.com

DBS for stroke is investigational use; clinical studies for this indication are conducted under Enspire's approved IDE from FDA.

About Enspire 
Enspire DBS Therapy, Inc. headquartered in Cleveland, OH, is a clinical stage medical device company focused on providing neuromodulation solutions to patients suffering with disabilities from stroke. Established in 2010, Enspire is a Cleveland Clinic portfolio company with the goal of commercializing novel technology. For more information, visit www.enspiredbs.com

SOURCE Enspire DBS Therapy, Inc.