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Electric implant aims to ease Amputees' lingering pain

NCT ID NCT07571239

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether an implanted device called Altius can reduce persistent pain in people who have lost a leg and still hurt despite prior nerve surgery. About 32 adults will get the device and report changes in pain, mood, and how often they use their prosthetic limb. The goal is to see if direct nerve stimulation can improve daily life for amputees with stubborn pain.

What this could mean

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

Active substance
Altius Direct Electrical Nerve Stimulation System (implanted device)
What this could lead to
If it works, this could offer a new way to manage stubborn pain after amputation and help people use their prosthetic limb more comfortably.
What could go wrong
This is a small, early study with only 32 people and no comparison group, so results may not apply to everyone. The device requires surgery and may not relieve pain for all users.

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 32 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

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 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 (≥18 years old) * Lower extremity amputees with prior TMR, RPNI at least 9 months prior to enrollment, or similar nerve-targeted surgery who have persistent neuropathic pain * Persistent chronic/intractable neuropathic pain that is moderate to severe (VAS ≥4) * 50% or greater pain reduction after receiving SOC ultrasound-guided lidocaine injection * Able and willing to provide consent Exclusion Criteria: * Non-LE amputees * LE amputees without moderate to significant pain * LE amputees who have not undergone TMR, RPNI, or similar nerve targeted surgeries, amputees who have undergone these surgeries less than 9 months prior to enrollment, or amputees who have undergone these surgeries and do not have persistent pain * Patients with contraindications to implant surgery * Presence of any active implantable device (e.g, pacemaker, implantable cardioverter-defibrillator, other neurostimulator or drug pump) * Anticipated need for MRI or diathermy after implantation * Uncontrolled diabetes, defined as HbA1c \> 8.0 at screening due to increased risk of surgical complications and delayed wound healing * Pregnant, breastfeeding, intending pregnancy during the study period, or unwilling to use effective contraception * Suspected or known allergy to any component of the Altius system or to lidocaine used for the diagnostic lidocaine block. * Severe scarring, skin grafting, or other anatomic constraints over the planned implant site that would prevent safe placement of the cuff electrode(s), lead(s), or IPG * Spasticity of the residual limb preventing comfortable full range of motion, which may interfere with stability or comfort of the implanted leads. * Other significant pain syndromes that, in the investigator's judgment, would likely confound assessment of phantom limb or residual limb neuropathic pain outcomes. * Active substance abuse; severe psychiatric illness that may interfere with study participation (e.g., recent psychiatric hospitalization or other condition that impairs ability to comply with study procedures); or inability to comply with follow up visits or operation of the Altius Direct Electrical Nerve Stimulation System. * Uncontrolled infection at the amputation site or bleeding disorders * Unable to operate the Altius® Direct Electrical Nerve Stimulation System * Unsuitable for the Altius implant surgery * Unable to participate in follow-ups according to study schedule (1 month, 3 months, and 6 months post-op)

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative

As listed by the trial registrant

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

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

  • NYU Langone Health

    New York, New York, 10016, United States