Enspire DBS Therapy, Inc. has reached a significant milestone in its RESTORE clinical trial program with the successful implantation of the first patient at Brown University Health in Providence, Rhode Island. This achievement marks the expansion of their pivotal Phase 2/3 study evaluating deep brain stimulation (DBS) combined with rehabilitation therapy for chronic upper extremity impairment in stroke survivors.
Dr. Wael Asaad, Director of the Functional Neurosurgery & Epilepsy Program at Brown University Health, emphasized the critical need for innovative treatments: "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. This potential treatment could give new hope to patients whose recovery has plateaued with the current options available."
Trial Design and Scope
The RESTORE trial plans to enroll approximately 40 patients across nine clinical centers. The study protocol involves implanting participants with a commercially available third-party DBS system, followed by a five-month outpatient rehabilitation program. Participants are initially randomized to either active-control (rehabilitation only) or treatment (DBS plus rehabilitation) groups. After five months of blinded testing, the active-control group transitions to receive DBS treatment with an additional five-month therapy program.
The trial is currently active at several prestigious institutions, including Cleveland Clinic, Massachusetts General Hospital, Mayo Clinic, and Medical University of South Carolina, with plans for additional site launches in the coming months.
Building on Previous Success
The RESTORE trial builds upon encouraging results from the EDEN proof-of-concept study, which demonstrated significant improvements in both motor impairment and function for patients 1-3 years post-stroke. The EDEN study, conducted at Cleveland Clinic, involved 12 participants with chronic, moderate-to-severe hemiparesis resulting from middle cerebral artery strokes.
Clinical Impact and Market Potential
Dr. Mark Pierre, Vice President of Clinical and Regulatory for Enspire, highlighted the significance of the trial's expansion: "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."
The potential impact of this therapy is substantial, considering that stroke affects approximately 800,000 people annually in the United States and remains the leading cause of long-term disabilities. About 50% of stroke survivors continue to require assistance with daily activities due to persistent disabilities.
Trial Implementation
The DBS system implementation involves surgical placement of electrodes in the cerebellum, followed by a structured rehabilitation program. This investigational therapy is being conducted under Enspire's FDA-approved Investigational Device Exemption (IDE).
Participating centers are actively recruiting eligible patients, with detailed information available through the study's dedicated website at www.restorestrokestudy.com. The trial's expansion represents a significant step forward in developing new treatment options for stroke survivors who have exhausted conventional rehabilitation methods.
