Five Cleveland biomedical research and healthcare institutions have received $1 million in grants from the National Institute of Neurological Disorders and Stroke (NINDS) within NIH to collaborate on developing the Cleveland Stroke Clinical Trials Regional Coordinating Center.
Case Western Reserve University School of Medicine will administer the five year grant through the Clinical Translational Science Collaborative (CTSC), an initiative that is in place to accelerate the progress of medical breakthroughs from research labs to patient care.
Under the five year grant, Case Western Reserve will work with CTSC partner institutions that includes Case Western’s School of Medicine and their primary affiliate University Hospitals Case Medical Center, Cleveland Clinic, MetroHealth Medical Center, and the Louis Stokes Cleveland VA Medical Center to improve prevention and treatment of stokes as well as provide rehabilitation for stroke patients.
The grant provides resources to advance collaboration among the major centers as well as the fourteen individual hospitals within their respective systems. The funding for the Regional Coordinating Center will go to support a centralized institutional review board for research projects, a project manager, and research coordinators. The will also develop, prioritize and implement stroke projects for the NINDS and train a new generation of young stroke clinical investigators.
In another project, the ongoing clinical trial “Rehabilitation of the Stroke Hand at Home” (NCT01144715) since 2010 has sponsored and collaborated on research with the Cleveland Clinic, Emory University, and with NINDS. The purpose of the research is to evaluate a therapy delivery system for stroke patients that provides accessible, affordable stroke care.
The clinical trial involves user friendly home therapy robots and a telerehabilitation system to monitor and provide therapy accessible for patients in rural and underserved locations. It is anticipated that the robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than the usual care.
The trial is testing the use of the Hand Mentor™ robotic stroke therapy device to improve the active range of motion in the distal musculature of the paretic limb of patients with stroke. The study is a multi-site randomized controlled trial.
A total of 96 patient six months post-stroke were enrolled and randomly assigned to one of the two groups. One group was the robotic based home therapy group and the other group was enrolled in a self-administered non-robotic home therapy program.
Another development involving clinical trials has enabled MicroTransponder www.microtransponder.com a medical device company spun out from the University of Texas, to complete a $3.39 million funding round to enable the company to complete three additional clinical trials using their neurostimulation system. The company will use the system to treat both stroke patients and tinnitus patients while developing their wireless pain platform.
The MicroTransponder’s Vivistim® System was developed to treat stroke patients that experience an upper-limb deficit following their stroke. These patients are unable to fully recover the use of their upper limbs for at least six months following their stroke.
A United Kingdom based clinical trial is underway using the Vivistim system in the Glasgow and Newcastle areas. The first patient has been implanted and is receiving therapy and a U.S. based stroke clinical trial is planned for 2014.