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Electrical Stimulation

Neuroprosthesis for Spinal Cord Injury (Trunk Protocol Trial)

N/A
Recruiting
Led By Ronald Triolo, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Controlled spasticity and absence of hip flexion and adduction spasm
C4-T12
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Trunk Protocol Trial Summary

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

Who is the study for?
This trial is for English-speaking adults with spinal cord injuries (quadriplegia or paraplegia) between C4-T12, ASIA Scale A-C. They should be stable post-injury (>6 months), without severe bone density issues, orthopedic problems, medical complications, psychological issues, or substance abuse. Participants need normal range of motion and body size and must not be pregnant.Check my eligibility
What is being tested?
The study tests an implanted device called IRS-8 that uses electrical currents to help stabilize the trunk and hips in people with spinal cord injuries. It aims to improve their ability to sit up straight, breathe easier, reach out, push a wheelchair more effectively, and roll over in bed.See study design
What are the potential side effects?
Potential side effects may include discomfort at the implant site, skin irritation from electrodes used during FES therapy sessions. There might also be muscle fatigue due to stimulated contractions.

Trunk Protocol Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My muscle stiffness is under control and I don't have spasms that pull my hip up or inward.
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My spinal injury is between the C4 and T12 vertebrae.
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I can move all my joints normally.
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I have not had issues with balance or unexpected falls.
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I have never had a bone break on its own or been told I have low bone density.
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I currently have no severe health issues.
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My spinal cord injury level is between complete and moderate.
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My height and weight are within the normal range.

Trunk Protocol Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.
Secondary outcome measures
Design a simple position controller

Trunk Protocol Trial Design

1Treatment groups
Experimental Treatment
Group I: NeuroprosthesisExperimental Treatment1 Intervention
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,620 Previous Clinical Trials
3,323,396 Total Patients Enrolled
Ronald Triolo, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
4 Previous Clinical Trials
46 Total Patients Enrolled

Media Library

IRS-8 (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT01474148 — N/A
Spinal Cord Injury Research Study Groups: Neuroprosthesis
Spinal Cord Injury Clinical Trial 2023: IRS-8 Highlights & Side Effects. Trial Name: NCT01474148 — N/A
IRS-8 (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01474148 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT01474148 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
Louis Stokes VA Medical Center, Cleveland, OH
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want to recover and possibly help others.
PatientReceived 2+ prior treatments
Recent research and studies
~1 spots leftby Jan 2025