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Neurostimulation Device

Nerve Stimulation for Diabetic Neuropathy

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

Being ambulatory and ability to stand or walk with prosthesis or orthosis

Chronic, medically stable lower limb amputation due to diabetes or insensate foot due to Diabetic peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years post implant

Awards & highlights

Study Summary

This trial will test whether electrical stimulation of residual nerves can provide sensation and improve function in people who have lost limbs due to diabetes.

Who is the study for?

This trial is for individuals with lower limb loss above or below the knee due to diabetes, who can walk or stand with assistance and have healthy nerves in their remaining limbs. They should have good skin health, no autoimmune issues, seizures, heart problems, and must be able to follow the study plan. Excluded are those with uncontrolled diabetes (HbA1c ≥ 8.5%), active skin ulcers, pregnancy, language barriers (non-English speakers), balance disorders, severe obesity (BMI > 35), mental health issues that affect study participation.Check my eligibility

What is being tested?

The trial tests implanted electrodes that provide sensation to nerves in the residual limb of amputees simulating natural feedback from a lost foot or leg. Additionally offered is an option for muscle recording electrodes aimed at creating intuitive control over robotic prosthetic legs through a motor controller.See study design

What are the potential side effects?

Potential side effects may include discomfort at electrode sites, possible skin irritation or infection risks associated with implants. There might also be unexpected nerve responses leading to pain or abnormal sensations.

Eligibility Criteria

Inclusion Criteria

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

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I can walk or stand using a prosthesis or brace.

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I have a stable lower limb amputation or insensate foot due to diabetes.

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I do not have autoimmune deficiencies, seizures, or heart problems that prevent stimulation treatments.

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My leg nerves respond well to standard nerve tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years post implant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years post implant

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years 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

Secondary outcome measures

Neuropathic Pain Syndrome Inventory (NPSI)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Multi contact electrode implant and implanted electromyography recording electrodesExperimental Treatment1 Intervention

Fifteen subjects with lower limb amputation will receive implanted multicontact stimulating nerve cuff electrodes connected to temporary percutaneous leads. During experimental testing, a small amount of stimulation will be applied to the nerves through the contacts of the multichannel cuff electrode.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,610 Previous Clinical Trials

3,305,169 Total Patients Enrolled

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

4 Previous Clinical Trials

41 Total Patients Enrolled

Media Library

Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04658693 — N/A

Diabetic Neuropathy Research Study Groups: Multi contact electrode implant and implanted electromyography recording electrodes

Diabetic Neuropathy Clinical Trial 2023: Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode Highlights & Side Effects. Trial Name: NCT04658693 — N/A

Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04658693 — N/A

Frequently Asked Questions

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

What is the uppermost limit for enrollees in this research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this experiment is actively seeking volunteers, with the initial listing posted on March 2nd 2021 and a recent edit made on February 3rd 2022. The study intends to recruit 10 individuals from one site."

Answered by AI

Is enrollment still available for the investigation?

"Affirmative. As per the information on clinicaltrials.gov, this study is actively recruiting participants and was first posted on March 2nd 2021. The research team requires 10 individuals to be enrolled from one location by February 3rd 2022."

Answered by AI