Actively Recruiting
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Led by VA Office of Research and Development · Updated on 2026-06-04
15
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
C
Case Western Reserve University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how to restore the sensation of a missing limb in individuals with above and below the knee amputations caused by diabetes or diabetic peripheral neuropathy. This study aims to understand how implanted electrodes that stimulate remaining nerves might send signals to the brain to mimic natural sensations. Additionally, the study explores the use of muscle recording electrodes to develop a motor control system for robotic prosthetic legs, potentially enabling intuitive movement. The study involves surgically implanting electrodes on one to four nerves in the residual limb and optionally placing intramuscular electrodes in lower limb and hip muscles to record muscle activity. Electrical pulses are delivered through an external wearable device to stimulate the nerves. An instrumented prosthesis will be used to create sensations that correspond to interactions with the ground while participants perform everyday activities such as standing, walking, or climbing stairs, including during visual or mental distractions. Participants will receive implanted multicontact stimulating nerve cuff electrodes connected to temporary leads, with stimulation applied during experimental testing. Researchers will assess stimulation thresholds at nine months and functional gait at six months after implant. Long-term outcomes, including neuropathic pain, will be monitored up to four years. Participants will be evaluated through various functional tasks and monitored for safety and effectiveness throughout the study period, which includes ongoing follow-up visits.
CONDITIONS
Brief Title
Functional and Neuroprotective Effects of Restoring Lower Limb Sensation After Diabetic Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic, medically stable lower limb amputation due to diabetes or insensate foot caused by diabetic peripheral neuropathy
- Ability to stand or walk using a prosthesis or orthosis
- Presence of viable target nerves in the lower limb confirmed by clinical tests
- Good skin condition and personal hygiene
- No autoimmune deficiencies, seizure disorders, or cardiac issues that prevent nerve stimulation
- Adequate social support and ability to follow study procedures and attend follow-up visits
You will not qualify if you...
- Presence of active pressure ulcers or chronic skin ulcerations
- Uncontrolled diabetes with HbA1c greater than or equal to 69 mmol/mol (8.5%)
- Significant vascular disease
- History of poor wound healing or uncontrolled infections
- Active infection
- Significant pain in the foot, residual limb, or phantom limb
- Pregnancy
- Inability to speak English sufficiently to describe sensations
- History of vestibular or movement disorders affecting balance or walking
- Class II or III obesity (Body Mass Index greater than 35)
- Uncontrolled mental health conditions such as depression, psychosis, or cognitive impairments
- Requirement for MRI during the study or while leads are implanted
- Arthritis causing inflammation or stiffness near the implant site
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgical procedure plus initial recovery period
Participants undergo surgical implantation of multi-contact stimulating nerve cuff electrodes and intramuscular electromyography recording electrodes in the residual limb and lower limb muscles.
1 surgical visit and several recovery visits
Duration - Up to 6 months post implant
Participants receive electrical stimulation through the implanted electrodes and use an external wearable device to control stimulation while wearing an instrumented prosthesis during functional tasks such as standing, walking, and climbing stairs.
Regular visits during the 6 months for device adjustments and functional assessments
Duration - Up to 4 years post implant
Participants are monitored for long-term neuroprotective effects and pain using clinical assessments and questionnaires.
Periodic follow-up visits for assessments
Trial Site Locations
Total: 1 location
1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
Research Team
R
Ronald Triolo, PhD
A
Aarika Sheehan, DPT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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