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Neuroprosthetics

Neuroprosthesis for Paralysis (LE-IST Trial)

N/A

Recruiting

Led By Ronald J Triolo, Ph.D.

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Range of motion within normal limits

Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from immediately after intervention and 1 year after intervention

Awards & highlights

LE-IST Trial 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.

Who is the study for?

This trial is for adults with paralysis due to spinal cord injury or conditions like stroke, who've been affected for over 6 months. They should have some intact nerve function and be able to move their joints normally. People with heart issues, pregnancy, joint contractures, severe lung/kidney/blood circulation problems, uncontrolled seizures or psychological issues, obesity, drug abuse, immune deficiencies or frequent infections can't join.Check my eligibility

What is being tested?

The study tests an implanted device called IST-16 that uses electrical stimulation to help people with paralysis exercise and improve movement like standing or stepping. It's surgically placed in the body and aims to restore some mobility functions.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 therapy sessions after surgery and possible infection risks associated with surgical implants.

LE-IST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can move all my joints normally.

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I have a spinal cord injury with significant loss of motor or sensory function.

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My lower motor neurons are functioning properly.

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I have a spinal cord injury between C6 and T12 or a condition that causes paralysis.

LE-IST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from immediately after intervention and 1 year after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from immediately after intervention and 1 year after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from immediately after intervention and 1 year after intervention for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge

Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge

Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge

+1 more

Secondary outcome measures

Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge

LE-IST Trial Design

1Treatment groups

Experimental Treatment

Group I: ImplantExperimental 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Western Reserve UniversityLead Sponsor

299 Previous Clinical Trials

259,940 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,697 Previous Clinical Trials

6,952,804 Total Patients Enrolled

US Department of Veterans AffairsFED

868 Previous Clinical Trials

487,880 Total Patients Enrolled

Media Library

IST-16 (Neuroprosthetics) Clinical Trial Eligibility Overview. Trial Name: NCT00623389 — N/A

Spinal Cord Injury Research Study Groups: Implant

Spinal Cord Injury Clinical Trial 2023: IST-16 Highlights & Side Effects. Trial Name: NCT00623389 — N/A

IST-16 (Neuroprosthetics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00623389 — N/A

Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT00623389 — N/A

Frequently Asked Questions

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

Are there current opportunities to participate in this trial?

"Clinicaltrials.gov 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."

Answered by AI

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

"Affirmative. According to clinicaltrials.gov, 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."

Answered by AI

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."

Answered by AI

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."

Answered by AI