SCI Program

Standing & Transfer

Participants gain the ability to stand independently for a defined period of time in order to perform transfers.

General Information on this clinical study

Principal Investigator: Ronald Triolo, Ph.D.

Clinical Coordinator: Lori Murray, P.T., M.S.

Contact Number: 216-778-3604

Contact Email: lmurray@fes.case.edu

Program Title: Standing, Exercise and Transfers with Implantable FES System

Purpose

This program examines the benefits of implanting a stimulation device to control muscles in the legs and trunk. The intended result is the ability to stand for defined periods of time and perform transfers with little to no assistance.

Program Description

The overall goal of this project is to enhance the personal mobility of individuals with spinal cord injuries (SCI) through the application of surgically implanted functional electrical stimulation (FES) technology in a small-scale multicenter clinical trial within the Veterans Healthcare System. Qualified implant candidates will be recruited at collaborating sites at VA centers in Baltimore, Houston and Lexington. Volunteers will receive the implanted system at the Cleveland FES Center and return to their home institutions for exercise, rehabilitation and follow-up data collection. After rehabilitation and reconditioning exercise, subjects will be trained to stand, balance and transfer with the neuroprosthesis and will be discharged to home for long-term follow-up. Data from collaborating sites will be pooled with those of subjects previously enrolled in Cleveland to demonstrate safety and support the filing of a Humanitarian Device Exemption with the US FDA.