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Neuroprosthetics

Neuroprosthesis for Spinal Cord Injury

N/A

Waitlist Available

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 spasms

Appropriate body habitus (BMI within normal range)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-rehabilitation

Awards & highlights

Study Summary

This trial is testing new methods to help people with SCI stand for longer periods of time without tiring, in order to improve their quality of life.

Who is the study for?

This trial is for adults over 21 with stable spinal cord injuries (C6-T12) causing paralysis, who have muscle control in their lower body and trunk. They must be able to consent, not have psychological issues or chemical dependency, and commit to follow-up procedures. Excluded are non-English speakers, pregnant individuals, those with diabetes or balance disorders, severe bone/joint problems, major medical complications like heart issues or infections.Check my eligibility

What is being tested?

The study tests a device called IST-16 designed to help people with spinal cord injuries stand longer by stimulating nerves in the legs and lower back. It alternates muscle activation using multiple-contact nerve electrodes to reduce fatigue during standing tasks.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site, muscle fatigue despite the technology's design to minimize it, skin irritation from electrode contact, and possible aggravation of spasticity due to electrical stimulation.

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 in my hip.

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My body mass index (BMI) is within the normal range.

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My hip socket is fully covered and my knees and ankles are not very loose.

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I am over 21 years old and can legally consent to treatment.

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My leg and lower back muscles respond normally to stimulation.

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I can fully move my hip, knee, and ankle without any restrictions.

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I have paralysis due to a spinal cord injury between C6 and T12.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-rehabilitation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-rehabilitation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-rehabilitation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Standing performance in terms of elapsed standing time will be compared across stimulation paradigms for each subject.

Secondary outcome measures

Body weight distribution on the arms and legs will be compared across stimulation paradigms for each subject.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NeuroprosthesisExperimental Treatment1 Intervention

Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IST-16 (16-Channel implanted stimulator-telemeter

2013

N/A

~10

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,609 Previous Clinical Trials

3,306,423 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,697 Previous Clinical Trials

7,492,313 Total Patients Enrolled

Ronald Triolo, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH

4 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

IST-16 (Neuroprosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT01923662 — N/A

Spinal Cord Injury Research Study Groups: Neuroprosthesis

Spinal Cord Injury Clinical Trial 2023: IST-16 Highlights & Side Effects. Trial Name: NCT01923662 — N/A

IST-16 (Neuroprosthetics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01923662 — N/A

Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT01923662 — N/A

Frequently Asked Questions

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

Is this clinical experiment presently looking for participants?

"Affirmative. Information hosted on clinicaltrials.gov reveals that this medical trial is actively seeking participants, with 10 patients required from a single location. The study was initially posted on April 11th 2013 and the most recent update was January 4th 2022."

Answered by AI

How many people can partake in this medical study?

"Affirmative. The information provided by clinicaltrials.gov confirms that this trial is currently recruiting participants, which was first posted on April 11th 2013 and most recently updated on January 4th 2022. This study requests 10 volunteers from a single site."

Answered by AI