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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 belowSelect...
My muscle stiffness is under control and I don't have spasms that pull my hip up or inward.
Select...
My spinal injury is between the C4 and T12 vertebrae.
Select...
I can move all my joints normally.
Select...
I have not had issues with balance or unexpected falls.
Select...
I have never had a bone break on its own or been told I have low bone density.
Select...
I currently have no severe health issues.
Select...
My spinal cord injury level is between complete and moderate.
Select...
My height and weight are within the normal range.
Trunk Protocol Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
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
1,610 Previous Clinical Trials
3,305,174 Total Patients Enrolled
Ronald Triolo, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
4 Previous Clinical Trials
46 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My muscle stiffness is under control and I don't have spasms that pull my hip up or inward.My spinal injury is between the C4 and T12 vertebrae.Your injury happened more than 6 months ago.I can move all my joints normally.I have not had issues with balance or unexpected falls.I have never had a bone break on its own or been told I have low bone density.I currently have no severe health issues.My spinal cord injury level is between complete and moderate.My trunk and pelvis muscles respond normally to stimulation.You do not have any ongoing mental health issues or problems with drug or alcohol addiction.I have a good support system and a stable living situation.I do not have any recent bone or joint issues.My height and weight are within the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Neuroprosthesis
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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