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

2014-07-23 21:56:50 | BioPortfolio

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.

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.

Study Design

Allocation: Non-Randomized, Primary Purpose: Treatment

Conditions

Spinal Cord Injury

Intervention

Surgery

Location

Case Western Reserve University
Cleveland
Ohio
United States
44106

Status

Completed

Source

Case Western Reserve University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:56:50-0400

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Medical and Biotech [MESH] Definitions

Repair of the damaged neuron function after SPINAL CORD INJURY or SPINAL CORD DISEASES.

A syndrome associated with traumatic injury to the cervical or upper thoracic regions of the spinal cord characterized by weakness in the arms with relative sparing of the legs and variable sensory loss. This condition is associated with ischemia, hemorrhage, or necrosis involving the central portions of the spinal cord. Corticospinal fibers destined for the legs are spared due to their more external location in the spinal cord. This clinical pattern may emerge during recovery from spinal shock. Deficits may be transient or permanent.

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