IST-16 (16-channel implanted stimulator-telemeter) for Spinal Cord Injury

Phase-Based Progress Estimates
MetroHealth System, Cleveland, OHSpinal Cord Injury+4 MoreIST-16 (16-channel implanted stimulator-telemeter) - Device
21 - 75
All Sexes
What conditions do you have?

Study Summary

This trial will test a surgically-implanted device that sends electrical signals to the muscles, to help people with paralysis exercise, stand, and/or maintain balance.

Eligible Conditions
  • Spinal Cord Injury
  • Quadriplegia
  • Paralysis
  • Paraplegia
  • Stroke

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Change from immediately after intervention and 1 year after intervention

Year 1
Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge
Device reliability and technical performance measuring changes in standing from baseline at discharge to 12 months after discharge
Device reliability and technical performance measuring changes in walking from baseline at discharge to 12 months after discharge

Trial Safety

Trial Design

1 Treatment Group

1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: IST-16 (16-channel implanted stimulator-telemeter) · No Placebo Group · N/A

Experimental Group · 1 Intervention: IST-16 (16-channel implanted stimulator-telemeter) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: change from immediately after intervention and 1 year after intervention

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor
276 Previous Clinical Trials
198,471 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,471 Previous Clinical Trials
24,591,538 Total Patients Enrolled
US Department of Veterans AffairsFED
854 Previous Clinical Trials
470,339 Total Patients Enrolled
Musa L Audu, Ph.D.Principal InvestigatorLouis Stokes Cleveland VA Medical Center
Ronald J Triolo, Ph.D.Principal InvestigatorCase Western Reserve University

Eligibility Criteria

Age 21 - 75 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to move your body normally.
You have a serious injury or condition that has caused paralysis in the lower part of your body, specifically from the neck down to the middle of your back.
Your bones are fully developed.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
Louis Stokes Cleveland VA Medical Center25.0%
MetroHealth System75.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I’m excited to try and improve my life"
  • "I have more life to live and I want to improve my condition. I also want to possibly help others with this new technology."
How many prior treatments have patients received?

How responsive is this trial?

Typically responds via
Most responsive sites:
  1. MetroHealth System: < 48 hours
Average response time
  • < 2 Days

Frequently Asked Questions

Are there current opportunities to participate in this trial?

" affirms that this medical study, which first opened to the public on June 1st 2018, is actively recruiting volunteers. Its last update was posted 5th October 2022." - Anonymous Online Contributor

Unverified Answer

How many participants are being treated as part of this experiment?

"Affirmative. According to, this medical program is actively enrolling participants since June 1st 2018 and its information was last revised on October 5th 2022. The researchers are in pursuit of 10 individuals from two separate facilities for the trial." - Anonymous Online Contributor

Unverified Answer

Is this study accepting volunteers of a mature age?

"The protocol of this medical trial specifies that the minimum age for participation is 21 years old and the maximum age limit is 75." - Anonymous Online Contributor

Unverified Answer

Is my eligibility sufficient to participate in this research?

"Eligibility requirements for this clinical trial necessitate that applicants have quadriplegia, with an age range of 21 to 75 years old. Only 10 participants may be accepted into the study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.