NCT00004445

Study of an Implantable Functional Neuromuscular Stimulation System for Patients With Spinal Cord Injuries

Eight Channel Implanted Neuroprosthesis for Exercise, Standing and Transfers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: 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.

Detailed description

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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
PROCEDURE	Surgery
DEVICE	IRS-8

Timeline

• Start date: 1996-09-01
• Primary completion: 2009-09-01
• Completion: 2016-12-31
• First posted: 1999-10-19
• Last updated: 2025-05-20
• Results posted: 2019-07-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study