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Evaluation of an Advanced Lower Extremity Neuroprostheses

NCT00623389 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Conditions

  • Spinal Cord Injuries
  • Stroke
  • Paralysis
  • Tetraplegia
  • Paraplegia

Interventions

DEVICE

IST (Implanted Stimulator-Telemeter)

Pre-surgical exercise with surface electrical stimulation, surgery including electrode and IST- implanted pulse generator insertion, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.

Sponsors & Collaborators

  • Case Western Reserve University

    lead OTHER

Principal Investigators

  • Ronald J Triolo, Ph.D. · Case Western Reserve University

  • Musa L Audu, Ph.D. · Louis Stokes Cleveland VA Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00623389 on ClinicalTrials.gov