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Multi-contact Electrode

Sensory Feedback Stimulation for Amputees

N/A
Recruiting
Led By Ronald Triolo, PhD
Research Sponsored by Louis Stokes VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials (SEP) and the like
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post implant
Awards & highlights

Study Summary

This trial is testing whether sensation can be restored in an amputated limb by electrical stimulation of the remaining nerves.

Who is the study for?
This trial is for adults over 18 with lower limb amputations who may use prostheses for standing or walking. They must have good nerve function in the remaining limb, stable health, and no severe skin issues. Excluded are those with chronic infections, obesity (BMI > 35), uncontrolled diabetes, balance disorders, significant mental health issues, or a need for MRI during the study.Check my eligibility
What is being tested?
The trial tests if stimulating nerves through implanted electrodes can restore sensation to amputees' missing limbs. It also explores whether recording electrodes in muscles can help control a robotic prosthetic leg intuitively.See study design
What are the potential side effects?
Possible side effects include discomfort at the electrode implant site, potential skin irritation or infection risks associated with implants and electrical stimulation-related sensations that might feel unnatural.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My leg nerves respond well to standard tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post implant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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
Functional Gait Assessment (FGA)
Stimulation Thresholds

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stimulating nerve electrodes & intramuscular recording electrodesExperimental Treatment1 Intervention
Fifteen subjects with lower limb amputation will have multi-contact stimulating nerve cuff electrodes implanted around the nerves in their residual limb. These electrodes will be connected to temporary percutaneous leads. During experimental testing, a small amount of electrical current will be delivered to the nerves through multi-contact nerve cuff electrodes. Participants also have the option to have recording electrodes implanted within muscles in their lower limb(s). These muscles are associated with prosthetic movement, and recordings from these muscles will be used to develop a controller for a robotic myoelectric prosthesis.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
863 Previous Clinical Trials
227,584 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
260,082 Total Patients Enrolled
Louis Stokes VA Medical CenterLead Sponsor
19 Previous Clinical Trials
3,320 Total Patients Enrolled

Media Library

Multi contact electrode implant (Multi-contact Electrode) Clinical Trial Eligibility Overview. Trial Name: NCT03409133 — N/A
Amputation Research Study Groups: Stimulating nerve electrodes & intramuscular recording electrodes
Amputation Clinical Trial 2023: Multi contact electrode implant Highlights & Side Effects. Trial Name: NCT03409133 — N/A
Multi contact electrode implant (Multi-contact Electrode) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03409133 — 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 participants can enroll in this research project?

"Affirmative. According to clinicaltrials.gov, this clinical trial is seeking participants with an initial posting date of November 5th 2015 and last update on October 14 2020. Specifically, the study needs 10 volunteers across 1 site in order to move forward."

Answered by AI

Are there any vacancies still available to join this research project?

"Affirmative, according to clinicaltrials.gov's data, this trial is searching for research participants now. It was initially posted on November 5th 2015 and the information has been updated as recently as October 14th 2020. The chosen medical centre needs 10 more patients in order to complete recruitment goals."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
How old are they?
18 - 65
What site did they apply to?
Louis Stokes VA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Feasibility of Sensory Feedback for Lower Limb Amputees
Ronald Triolo 2015. "Feasibility of Sensory Feedback for Lower Limb Amputees". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03409133.
~4 spots leftby Sep 2027
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