Electric implant aims to ease Amputees' lingering pain
NCT ID NCT07571239
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
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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
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About 32 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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NYU Langone Health
New York, New York, 10016, United States