IRS-8 (8-Channel implanted stimulator-telemeter) for Spinal Cord Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, OHSpinal Cord Injury+3 MoreIRS-8 (8-Channel implanted stimulator-telemeter) - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to help people with spinal cord injuries move their bodies using electrical stimulation.

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

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: up to 36 months

Up to 36 months
Design a simple position controller
up to 36 months
Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.

Trial Safety

Trial Design

1 Treatment Group

Neuroprosthesis
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: IRS-8 (8-Channel implanted stimulator-telemeter) · No Placebo Group · N/A

Neuroprosthesis
Device
Experimental Group · 1 Intervention: IRS-8 (8-Channel implanted stimulator-telemeter) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,495 Previous Clinical Trials
2,724,252 Total Patients Enrolled
Ronald Triolo, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
4 Previous Clinical Trials
45 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 14 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
It has been more than 6 months since your injury occurred.
You have muscles in your trunk and pelvis that can be moved and controlled by your nerves.
You do not have any mental health issues or addiction problems.
You are able to move normally.
You are able to control your muscle spasms and do not experience spasms in your hip muscles.
You do not have any sudden medical problems.
You don't have any sudden bone or joint problems.
You have a spinal cord injury between the fourth cervical and twelfth thoracic vertebrae.
You have enough support and a stable living situation.

Who else is applying?

What state do they live in?
Pennsylvania100.0%
What site did they apply to?
Louis Stokes VA Medical Center, Cleveland, OH100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I want to recover and possibly help others"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

How many individuals are taking part in this clinical trial?

"The trial is ongoing, as reflected by the most recent update on clinicaltrials.gov occurring on February 2nd, 2022. This study was initially posted on November 30th, 2011 and is enrolling 10 patients at a single site." - Anonymous Online Contributor

Unverified Answer

Are new participants still being sought for this experiment?

"The study, which is detailed on clinicaltrials.gov, is looking for more participants. According to the website, the trial was first announced on November 30th, 2011 and has since been updated on February 2nd, 2022." - 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.