Feasibility of Neural Feedback for Lower Limb Amputees

This study is exploring a new way to provide sensation to people who have lost a lower limb, either above or below the knee. It uses stimulating nerve electrodes, which are small devices surgically placed on your remaining nerves. These electrodes deliver tiny electrical currents that aim to create feelings in your missing limb, similar to how your brain used to receive information from your foot and lower leg. The study will measure how much electrical stimulation is needed to create these sensations (Stimulation Thresholds) and how well you can walk and move (Functional Gait Assessment) after the electrodes are implanted. You might also have the option to have recording electrodes placed in your muscles to help develop a robotic prosthetic leg that you can control more intuitively. Adults aged 18 or older with stable amputations and viable nerves are eligible to participate. The current status of the study is unclear, and it plans to enroll 15 participants.

Study design
This is an interventional study with a planned enrollment of 15 participants. It is not specified if it is randomized or blinded.
What's involved
Electrodes will be surgically implanted on one to four nerves. You will describe perceived sensations and wear an instrumented prosthesis for various functional tasks. You may also have recording electrodes implanted in your muscles.
Compensation
Not stated in the trial record.
Follow-up
Stimulation thresholds will be measured at 9 months post-implant, and functional gait assessment will be measured at 1 year post-implant.

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NCT03409133

Feasibility of Neural Feedback for Lower Limb Amputees

Recruiting
NAAges 18+InterventionalDevice feasibility
Louis Stokes VA Medical Center
~15 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:Stimulating nerve electrodes and intramuscular recording electrodes

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stimulation Thresholds
Measured over 9 months post implant
+1 more outcome measured
Amputation

NCT03409133

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Louis Stokes VA Medical Center

    Cleveland, Ohiostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Ronald Triolo, PhD · PRINCIPAL_INVESTIGATOR · Louis Stokes VA Medical Center

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Eligibility criteria

Inclusion

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

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.
  • Stimulation Thresholds9 months post implant

    Quantify the minimum stimulation required to evoke electrically induced sensations on the phantom limb.

  • Functional Gait Assessment (FGA)1 year post implant

    The Functional Gait Assessment is a 10 task test that measures postural stability. Each task is scored from 0 -3 with 0 indicating severe impairment in the task and 3 indicating normal ambulation. The scores are combined to give a total score. The maximum score is 30. A higher score indicates a better outcome.