Enspire DBS Therapy Announces the First Patient Implanted in the Second Center for RESTORE, a Multicenter Pivotal Phase 2/3 Clinical Trial for the Treatment of Arm Weakness and Reduced Function after Stroke

• The first patient implanted at Brown University Health marks the expansion of the study to multiple clinical sites
• RESTORE aims to generate the data necessary to demonstrate the long-term safety and efficacy of DBS+Rehab in stroke patients to support marketing approval

CLEVELAND, March 4, 2025 /PRNewswire/ -- Enspire DBS Therapy, Inc., (Enspire) a clinical-stage company developing an implantable neuromodulation therapy for post-stroke recovery, announced today the first patient implanted in its second clinical trial site for RESTORE, a pivotal phase 2/3 multi-center trial evaluating the safety and effectiveness of deep brain stimulation (DBS) combined with rehab therapy (DBS + Rehab) to treat patients with chronic upper extremity impairment due to stroke. The patient was implanted at Brown University Health in Providence, RI.

"There is an urgent need for new treatment options for people who suffer stroke, particularly those who are experiencing residual upper extremity impairment even after the current therapies and rehabilitation," said Wael Asaad, MD, PhD, Director of the Functional Neurosurgery & Epilepsy Program at Brown University Health, "This potential treatment could give new hope to patients whose recovery has plateaued with the current options available."

There are a total of nine clinical trial centers and approximately 40 patients planned for RESTORE, which builds on the promising results observed in the proof-of-concept study, EDEN. In EDEN the combination therapy of DBS+Rehab demonstrated significant improvements in both motor impairment and function for patients 1-3 years post-stroke. Sites currently seeking patients for RESTORE include Brown University Health (Providence, RI), Cleveland Clinic (Cleveland, OH), Massachusetts General Hospital (Boston, MA), Mayo Clinic (Rochester, MN), and Medical University of South Carolina (Charleston, SC). 

Dr. Mark Pierre, Vice President, Clinical and Regulatory for Enspire, said, "The expansion of RESTORE to multiple clinical sites is a critical step in gathering the data necessary to demonstrate the long-term safety and efficacy of DBS+Rehab in stroke patients to support marketing approval. We are pleased to be working with the Cleveland Clinic, Brown University Health, and our other clinical sites on this important initiative. We look forward to launching additional sites in the coming months." 

About Stroke
Approximately 800,000 people in the United States suffer strokes each year, making it the leading cause of long-term disabilities. While most patients will survive the acute phase, persistent neurological issues often compromise quality of life and productivity, with approximately 50% of stroke survivors continuing to experience disabilities severe enough to require assistance with daily activities.

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 undergo a five-month outpatient rehabilitation therapy program. During the first phase, participants will be randomized to either active-control (rehab only) or treatment (DBS + rehab). After five months of blinded randomized testing, participants in the active-control group will cross over to receive DBS treatment and continue with a second five-month therapy program. For more information, see ClinicalTrials.gov ID NCT05701280.

The RESTORE trial is active at the following clinical sites: Brown University Health (Providence, RI), Cleveland Clinic (Cleveland, OH), Massachusetts General Hospital (Boston, MA), Mayo Clinic (Rochester, MN), and Medical University of South Carolina (Charleston, SC). Interested parties should go to www.restorestrokestudy.com for more information.

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

About EDEN
The EDEN Study, conducted at The Cleveland Clinic, enrolled 12 individuals with chronic, moderate-to-severe hemiparesis of the upper extremity resulting from a unilateral middle cerebral artery (MCA) stroke occurring 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 two months and then turned on for four-to-eight months.  

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 from disabilities from stroke. Established in 2010, Enspire is a Cleveland Clinic portfolio company with the goal of commercializing novel therapies. For more information, visit www.enspiredbs.com

About Brown University Health

Formed in 1994, Brown University Health is a not-for-profit health system based in Providence, RI comprised of three teaching hospitals of The Warren Alpert Medical School of Brown University: Rhode Island Hospital and its Hasbro Children's Hospital; The Miriam Hospital; and Bradley Hospital, the nation's first psychiatric hospital for children; Newport Hospital, a community hospital offering a broad range of health services; Gateway Healthcare, the state's largest provider of community behavioral health care; Brown Health Medical Group, the largest multi-specialty practice in Rhode Island; and Brown Health Medical Group Primary Care, a primary care driven medical practice. Brown University Health teaching hospitals are among the country's top recipients of research funding from the National Institutes of Health. The hospitals received over $145 million in external research funding in fiscal 2023. All Brown University Health-affiliated partners are charitable organizations that depend on support from the community to provide programs and services.

SOURCE Enspire DBS Therapy, Inc.