Nerve Stimulation for Diabetic Neuropathy
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is nerve stimulation for diabetic neuropathy generally safe in humans?
How does the implanted multi-contact stimulating electrode treatment for diabetic neuropathy differ from other treatments?
This treatment is unique because it involves implanting electrodes directly into the body to stimulate nerves and record muscle activity, which can provide more precise control and feedback compared to traditional treatments that do not use implanted devices. It offers a novel approach by potentially restoring sensory and motor functions through direct nerve stimulation and recording, which is not typically available in standard diabetic neuropathy treatments.46789
What data supports the effectiveness of the treatment Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode for diabetic neuropathy?
Research on similar electrode implants shows they can reliably stimulate and record nerve activity, which may help restore motor and sensory functions. Studies in animals demonstrate that these implants can evoke muscle responses and maintain stable nerve recordings over time, suggesting potential benefits for conditions like diabetic neuropathy.78101112
Who Is on the Research Team?
Ronald Triolo, PhD
Principal Investigator
Louis Stokes VA Medical Center, Cleveland, OH
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgical Implantation
Electrodes are surgically implanted on one to four nerves of the residual limb and intramuscular recording electrodes can be implanted in the lower limbs and hip muscles.
Treatment
Participants receive stimulation through implanted electrodes to restore sensation and develop a motor controller for a robotic prosthetic leg.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of neuropathic pain and functional gait.
What Are the Treatments Tested in This Trial?
Interventions
- Implanted Multi contact stimulating electrode and intramuscular electromyography recording electrode
- Multi contact electrode implant
Find a Clinic Near You
Who Is Running the Clinical Trial?
VA Office of Research and Development
Lead Sponsor