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Study of an Implantable Functional Neuromuscular Stimulation System for Patients with Spinal Cord Injuries
This study is currently recruiting patients.
Sponsored by: | FDA Office of Orphan Products Development Case Western Reserve University
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Information provided by: | FDA Office of Orphan Products Development |
Purpose
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.
Condition | Treatment or Intervention |
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Spinal Cord Injury |
Procedure: Surgery |
MedlinePlus related topics: Spinal Cord Injuries
Study Type: Interventional
Study Design: Treatment, Non-Randomized
Expected Total Enrollment: 17
Study start: September 1996
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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