Enspire DBS Therapy Implements First Patient at Brown University for RESTORE Clinical Trial on Stroke Recovery

Enspire DBS Therapy Expands RESTORE Clinical Trial

Enspire DBS Therapy, Inc., based in Cleveland, has made significant strides in the field of post-stroke recovery by announcing the successful implantation of the first patient at Brown University Health. This marks a pivotal milestone in the RESTORE clinical trial, a multi-center phase 2/3 study aimed at evaluating the effectiveness and safety of deep brain stimulation (DBS) combined with rehabilitation therapy for patients suffering from chronic upper extremity impairment following a stroke.

A Growing Need for Innovative Treatments

Stroke is a leading cause of long-term disabilities in the United States, affecting approximately 800,000 individuals annually. Many stroke survivors face challenges in regaining full functionality, with nearly 50% continuing to experience significant impairments that hinder their ability to carry out daily activities.

Dr. Wael Asaad, a leading expert at Brown University Health, emphasized the urgent need for new treatment options for patients whose recovery has stagnated despite existing therapies. The introduction of DBS in combination with rehabilitation seeks to provide renewed hope for this demographic, offering a novel approach to enhance their recovery.

RESTORE Trial: Goals and Structure

The RESTORE trial is set to enroll around 40 patients across nine clinical trial centers, which includes esteemed institutions such as the Cleveland Clinic, Massachusetts General Hospital, and the Mayo Clinic. The trial builds on the promising initial findings from the EDEN study, where patients exhibited significant improvements in motor function and capabilities between one to three years post-stroke when undergoing DBS and rehabilitation therapy.

During the RESTORE trial, participants will first be randomized to receive either standard rehabilitation or the combined therapy of DBS and rehabilitation. After a span of five months, individuals in the control group will have the opportunity to switch to the active treatment group, allowing both groups access to the innovative therapy during the study period.

Dr. Mark Pierre, Enspire's Vice President of Clinical and Regulatory Affairs, expressed enthusiasm about the multi-center expansion of the RESTORE trial, which is crucial for amassing the necessary data to gain marketing approval for this innovative therapy that combines DBS with rehabilitation techniques.

Implications of Stroke Recovery Innovations

As a result of the RESTORE trial, the landscape of stroke recovery therapy may see substantial improvement, impacting the lives of many individuals grappling with severe disabilities. Each participant will undergo a thorough program involving the implantation of a commercially available DBS system followed by an intensive outpatient rehabilitation program lasting about five months.

The implications of the trial are profound as successful outcomes could lead to regulatory approval, subsequently transforming current treatment paradigms in stroke care. Current clinical studies, including RESTORE, emphasize pioneering therapeutic avenues aimed at significantly enhancing the quality of life for stroke survivors.

About Enspire DBS Therapy

Founded in 2010 and headquartered in Cleveland, Ohio, Enspire DBS Therapy seeks to shed light on novel neuromodulation solutions aimed at improving the lives of patients enduring post-stroke disabilities. The company operates under the framework of a collaborative portfolio with the Cleveland Clinic, striving to bring groundbreaking therapies to market.

As the RESTORE trial progresses, stakeholders remain hopeful for a future where effective recovery solutions abound for individuals affected by stroke. For further details and updates regarding clinical trials, interested parties can visit ClinicalTrials.gov and search for the trial ID NCT05701280.

In conclusion, Enspire's efforts to initiate the RESTORE trial at Brown University Health represents a significant advancement in addressing the urgent need for effective stroke recovery therapies. As the trial unfolds, the medical community watches closely, hopeful for breakthroughs that can dramatically alter the post-stroke recovery landscape.