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Could a simple nerve stimulation device ease phantom limb pain?

NCT ID NCT07448350

Symptom relief Sponsor: Campus Bio-Medico University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether Transcutaneous Electrical Nerve Stimulation (TENS) can reduce phantom limb pain and improve walking in people with a leg amputation. Fifteen adults with above- or below-knee amputations will receive daily TENS sessions for four weeks. Researchers will measure changes in pain perception, balance, and gait.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcutaneous Electrical Nerve Stimulation (TENS)
What this could lead to
If it works, this could offer a non-drug way to ease phantom limb pain and improve walking for people with leg amputations.
What could go wrong
This is a very small, early study with only 15 people, so results may not apply widely. TENS may not reduce pain for everyone.

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.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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: * Age between 18 and 80 years; * unilateral TTA or TFA at least two months prior the study; * stable clinical conditions; * skin integrity; * absence of cognitive deficits; * able to walk using the prosthesis; * no previous experience with TENS. Exclusion Criteria: * Bilateral amputation; * open wounds or sores on the residual limb; * cognitive deficits; * pregnancy; * presence of implanted medical device (e.g., cardiac defibrillators, pacemakers or infusion pumps); * refusal to sign the informed consent.

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As listed by the trial registrant

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

Lower limb amputation above knee Lower limb amputation below knee

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

  • Don Gnocchi Foundation

    RECRUITING

    Rome, Rome, 00168, Italy

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