Using nerve feedback to help lower limb amputees feel sensations in their prosthetics
Feasibility of Neural Feedback for Lower Limb Amputees
This study tests whether giving nerve feedback through small electrical currents can help lower limb amputees feel sensations in their prosthetics and control them better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Louis Stokes VA Medical Center Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03409133 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of providing sensory feedback to individuals with lower limb amputations through the use of implanted electrodes that stimulate remaining nerves. By delivering small electrical currents to these nerves, the study aims to recreate the sensations of the missing limb, allowing participants to perceive interactions with their prosthetic devices. Additionally, the study explores the use of intramuscular recording electrodes to develop a motor controller for intuitive control of robotic prosthetic legs. Participants will engage in various functional tasks while wearing a sensory neuroprosthesis to assess the effectiveness of the approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with chronic, stable unilateral trans-tibial or trans-femoral amputations who are potential users of prostheses.
Not a fit: Patients with uncontrolled diabetes, significant vascular disease, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life for amputees by restoring sensory feedback and improving control over their prosthetic limbs.
How similar studies have performed: Other studies have shown promise in using nerve stimulation for sensory feedback in amputees, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults age 18 or greater * Chronic, medically stable ( \> 3 months) trans-tibial or trans-femoral amputation at the time of implant surgery. * Potential user of trans-tibial or trans-femoral prostheses for standing or walking * Viable target nerves in the lower extremity as determined by standard-of-care clinical tests of nerve conduction, response to stimulation, sensory evoked potentials and the like * Good skin integrity and personal hygiene * Absence of autoimmune deficiencies, seizure disorders or cardiac abnormalities contraindicating stimulation * Sufficient social support and personal ability to tolerate study procedures and comply with follow-up schedule Exclusion Criteria: * Uncontrolled diabetes to a degree that would preclude surgery * Significant vascular disease * Chronic skin ulcerations * Significant history of poor wound healing * Significant history of uncontrolled infections * Active infection * Significant pain in the residual or phantom limb * Pregnancy * Inability to speak English * Expectation that MRI will be required at any point for the duration of study or while percutaneous leads are in place * Severe neurological conditions that significantly impair balance or mobility to an extent that independent ambulation is impossible without assistance ( as determined by a healthcare provider) * Appropriate body habitus (height and weight within acceptable limits as determined by study physician) * Poor surgical candidate * Psychiatric or cognitive conditions that could affect cooperation or understanding of instructions and willingness to undergo psychological evaluation, if recommended by study surgeons or investigators.
Where this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ronald Triolo, PhD — Louis Stokes VA Medical Center
- Study coordinator: Aarika Sheehan, PT, DPT
- Email: Aarika.Sheehan@va.gov
- Phone: 216-791-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.