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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
Must not have
Arthritis in the area of implant- Inflammation or stiffness in the area of implant could limit placement of the electrodes
Significant history of uncontrolled infections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years post implant
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to help people who have lost a leg by using small devices that send electrical signals to nerves and record muscle activity. These signals help the brain feel sensations from the missing limb, and the muscle data helps control a robotic leg more naturally.
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.
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.
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 belowSelect...
I can walk or stand using a prosthesis or brace.
Select...
I have a stable lower limb amputation or insensate foot due to diabetes.
Select...
I do not have autoimmune deficiencies, seizures, or heart problems that prevent stimulation treatments.
Select...
My leg nerves respond well to standard nerve tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have arthritis near where a medical device was implanted.
Select...
I have a history of infections that were hard to control.
Select...
My diabetes is not under control, with an HbA1c of 8.5% or higher.
Select...
I have serious blood vessel problems.
Select...
I have ongoing skin sores or ulcers.
Select...
I have a history of disorders affecting my balance or walking.
Select...
My BMI is over 35, indicating I have class II or III obesity.
Select...
I currently have an infection.
Select...
I experience significant pain in my foot, including after amputation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years post implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years post implant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Functional Gait Assessment (FGA)
Stimulation thresholds
Secondary study objectives
Neuropathic Pain Syndrome Inventory (NPSI)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for diabetic neuropathy include the use of antioxidants like alpha-lipoic acid, antiepileptic drugs such as gabapentin, and electrical stimulation of nerves. Alpha-lipoic acid works by reducing oxidative stress and improving nerve blood flow, which can alleviate symptoms.
Gabapentin modulates neurotransmitter release to reduce pain. Electrical stimulation of nerves, as studied in trials with stimulating electrodes, sends small electrical currents to remaining nerves, mimicking natural nerve signals to the brain.
This can help restore sensation and improve motor control. Understanding these mechanisms is crucial for patients as it highlights how these treatments can alleviate symptoms, improve quality of life, and potentially slow disease progression.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,665 Previous Clinical Trials
3,765,799 Total Patients Enrolled
Ronald Triolo, PhDPrincipal InvestigatorLouis Stokes VA Medical Center, Cleveland, OH
4 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have arthritis near where a medical device was implanted.You have severe mental illness or problems with memory and thinking that may make it hard for you to follow the study schedule.You expect to need MRI scans during the study, or you have a type of medical device that makes MRI scans unsafe for you.I have a history of infections that were hard to control.I can walk or stand using a prosthesis or brace.My diabetes is not under control, with an HbA1c of 8.5% or higher.I have serious blood vessel problems.I have a stable lower limb amputation or insensate foot due to diabetes.I do not have autoimmune deficiencies, seizures, or heart problems that prevent stimulation treatments.My leg nerves respond well to standard nerve tests.I have ongoing skin sores or ulcers.I have a history of disorders affecting my balance or walking.My BMI is over 35, indicating I have class II or III obesity.You have a history of healing slowly after getting hurt.I take good care of my skin and personal hygiene.I currently have an infection.I experience significant pain in my foot, including after amputation.
Research Study Groups:
This trial has the following groups:- Group 1: Multi contact electrode implant and implanted electromyography recording electrodes
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.