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

NCT00004445 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-20

Study results available
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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.

Conditions

  • Spinal Cord Injury

Interventions

PROCEDURE

Surgery

DEVICE

IRS-8

Sponsors & Collaborators

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Ronald J. Triolo · Case Western Reserve University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-09-30
Primary Completion
2009-09-30
Completion
2016-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004445 on ClinicalTrials.gov