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Clinical Trial Summary

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.


Clinical Trial Description

In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip musculature. The electrode leads are connected to a stimulator/telemeter located in the abdomen. After a typical post-operative period of two to five days, neuroprosthesis recipients will be discharged to home for two to six weeks of restricted activity to promote healing of all surgical incisions. After a period of exercise and training, functional use of the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional abilities with and without the system, as well as the technical performance of the implanted components will be evaluated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01474148
Study type Interventional
Source VA Office of Research and Development
Contact Lisa M Lombardo, MPT
Phone (216) 791-3800
Email Lisa.Lombardo2@va.gov
Status Recruiting
Phase N/A
Start date November 30, 2011
Completion date January 31, 2025

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