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Neurostimulation Device

Stimulator Implant for Stroke Recovery

N/A
Recruiting
Led By Nathan Makowski, PhD
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to ambulate, but does not require the assistance of more than one person
Innervated and excitable lower extremity and trunk musculature
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, ~18 weeks post implant, ~44-week post implant
Awards & highlights

Study Summary

This trial will evaluate if a stimulator implant can help stroke survivors walk better. It includes two phases of testing and implantation.

Who is the study for?
This trial is for stroke survivors aged 21-75 who walk slower than normal due to the stroke. They should be at least 6 months post-stroke, have certain levels of muscle stiffness and motor function, and not need more than one person's help to walk. Participants must also be neurologically stable, speak English, not pregnant, without severe cognitive issues or medical conditions that increase fall risk.Check my eligibility
What is being tested?
The study tests an implanted stimulator device designed to improve walking in people with gait disorders after a stroke. It involves screening candidates for eligibility, implanting the device, setting up home use controllers for walking improvement and evaluating its effects over several months.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include discomfort at the implant site, potential infection risk from surgery or hardware malfunction leading to abnormal sensations or movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk with help from no more than one person.
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My leg and lower back muscles respond normally to stimulation.
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I have limited movement in my hip, knee, or ankle when walking.
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My muscle stiffness in certain joints is mild to moderate.
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I walk slower than a certain speed during a short test.
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My leg movement is severely limited.
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I am between 21 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, ~18 weeks post implant, ~44 week post implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, ~18 weeks post implant, ~44 week post implant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Difference in Gait speed
Secondary outcome measures
Difference in Usability Rating Scale (URS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Implantation, controller development, and evaluationExperimental Treatment2 Interventions
This phase includes installing the device and setting the individual up for home use, creating advanced controllers for walking and evaluating the effect of the device over several months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IRS-8
1996
N/A
~20

Find a Location

Who is running the clinical trial?

Cleveland State UniversityOTHER
12 Previous Clinical Trials
2,063 Total Patients Enrolled
MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,383 Total Patients Enrolled
6 Trials studying Hemiplegia
473 Patients Enrolled for Hemiplegia
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
260,091 Total Patients Enrolled
4 Trials studying Hemiplegia
278 Patients Enrolled for Hemiplegia

Media Library

IRS-8 (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05740540 — N/A
Hemiplegia Research Study Groups: Implantation, controller development, and evaluation
Hemiplegia Clinical Trial 2023: IRS-8 Highlights & Side Effects. Trial Name: NCT05740540 — N/A
IRS-8 (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05740540 — N/A

Frequently Asked Questions

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

Which demographics can sign up to take part in this investigation?

"To become a participant in this clinical trial, individuals must be between 21 and 75 years of age with a stroke diagnosis. There are 6 openings available."

Answered by AI

Does this research program still have availability for participants?

"According to the latest information on clinicaltrials.gov, this medical experiment is still in search of participants. It was initially posted on November 30th 2022 and its most recent update happened on February 13th 2023."

Answered by AI

Does the research team include elderly participants aged 80 and over?

"To qualify for this trial, the individual must be between 21 and 75 years of age. Patients that are younger than 18 can opt to join one of 43 other studies available while those over 65 may choose from 1043 different clinical trials."

Answered by AI

How many participants have been invited to take part in this project?

"Indeed, the data posted on clinicaltrials.gov verifies that this medical trial is currently recruiting participants. This project was initially launched on November 30th 2022 and recently updated on February 13th 2023. At present, 6 individuals are needed between two distinct locations."

Answered by AI

Who else is applying?

What site did they apply to?
Louis Stokes Cleveland Veterans Affairs Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I have still disability due to my stroke.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Implant for Walking After Stroke
Nathaniel Makowski 2023. "Implant for Walking After Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05740540.
All > Hemiplegia
~4 spots leftby Mar 2027
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