Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries
I. Establish the procedures for implementing and assessing the clinical utility of functional neuromuscular stimulation using an implanted eight-channel standing and transfer system in patients with incomplete tetraplegia or paraplegia.
II. Develop and apply quantitative functional evaluations of system performance in these patients.
III. Perform long term follow up and monitor system use outside of the laboratory.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Standing performance [ Time Frame: Discharge, 6 months and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 1996|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
Experimental: Implanted Neuroprosthesis
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in [ost-operative training and follow-up procedures.
|Procedure: Surgery Device: IRS-8|
PROTOCOL OUTLINE: Patients undergo surgery in which electrodes are sutured into areas of the pelvis and legs. Electrode leads are inserted into a receiver/stimulator implanted in a subcutaneous pocket in the abdomen. Following implantation, patients undergo training in standing, transfers, and other advanced mobility skills using the functional neuromuscular stimulation system. Restricted activity continues for 2 weeks after surgery, followed by 8 weeks of exercise. Standing training then begins, and continues for up to 6 weeks. Home-based training follows prior to discharge with the system for spontaneous use.
Patients are followed at 3, 6, and 12 months, then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004445
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Cleveland, Ohio, United States, 44109|
|Study Chair:||Ronald J. Triolo||Case Western Reserve University|