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Shocking nerves back to life: new hope for amputees

NCT ID NCT03409133

Symptom relief Sponsor: Louis Stokes VA Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether small electrical currents delivered to nerves in the leg can restore sensation of a missing foot or limb in 15 adults with above- or below-knee amputations. Participants may also get muscle implants to help control a robotic leg. The goal is to improve walking and quality of life, not to cure the amputation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2015

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Phantom Limb

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Amputation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Louis Stokes VA Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.