Evaluation of an Advanced Lower Extremity Neuroprostheses for Paralysis

This study is evaluating a surgically implanted system called IST (Implanted Stimulator-Telemeter) for people with paralysis from conditions like spinal cord injuries or stroke. The IST system uses electrical stimulation to help with exercise, standing, stepping, and balance. To join, you must be between 21 and 75 years old, have skeletal maturity, and have paralysis that is not ventilator-dependent, affecting your trunk and/or lower limbs. Researchers will measure how well the device works and its technical performance by looking at changes in how long you can stand, how much weight you can bear while standing, and how far you can walk, from immediately after the intervention to 12 months later. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo surgery to implant electrodes and the IST system, followed by training and rehabilitation with the system. This includes exercise, functional training, and laboratory assessments, with home-based training before discharge.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed at 6 and 12 months after discharge, and then annually thereafter.

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NCT00623389

Evaluation of an Advanced Lower Extremity Neuroprostheses

Recruiting
NAAges 21–75InterventionalDevice feasibility
Case Western Reserve University
~10 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:IST (Implanted Stimulator-Telemeter)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
Measured over Change from immediately after intervention and 1 year after intervention
+3 more outcomes measured
Spinal Cord Injuries
Stroke
Paralysis
Tetraplegia
Paraplegia
2 sites across 1 states
Ohio2
  • Ronald J Triolo, Ph.D. · PRINCIPAL_INVESTIGATOR · Case Western Reserve University
  • Musa L Audu, Ph.D. · PRINCIPAL_INVESTIGATOR · Louis Stokes Cleveland VA Medical Center

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  • Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after dischargeChange from immediately after intervention and 1 year after intervention

    Repeated measures of standing duration in minutes

  • Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after dischargeChange from immediately after intervention and 1 year after intervention

    Repeated measures of arm/leg loading measured in Kg

  • Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after dischargeChange from immediately after intervention and 1 year after intervention

    Repeated measures of walking distance in meters

  • Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after dischargeChange from immediately after intervention and 1 year after intervention

    Repeated measures of walking time in minutes