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Altius Peripheral Nerve Stimulation for Amputee Pain

This study is testing the Altius system, a surgically implanted device, to help amputees with ongoing pain in their lower limbs. You might be able to join if you are an adult (18 or older) who has had a lower leg amputation and a previous nerve-targeted surgery (like TMR or RPNI) at least nine months ago. You should also have moderate to severe nerve pain that improved by at least 50% after a lidocaine injection. The study will look at how much you use your prosthetic limb and how well it functions over six months. The goal is to see if the Altius system helps reduce pain and improve prosthetic use. This study plans to enroll 32 participants.

Study design
This is a single-center study involving 32 participants who will all receive the Altius system. It is a "within-subject" study, meaning each participant's progress is compared to their own starting point.
What's involved
You will have the Altius system surgically implanted once. You will then complete questionnaires about your pain, demographics, and medical history, and be followed over time.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for at least six months after the Altius system is implanted, with measurements taken at one, three, and six months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07571239

Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
NYU Langone Health
~32 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Surgical Implantation

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Hours Per Day of Prosthesis Use
Measured over Baseline, Month 1, Month 3, Month 6
+4 more outcomes measured

Conditions

Amputation; Lower Extremity
Pain, Persistent Postsurgical

Explore related trials

Amputated lower limbNeuropathic Pain

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Jacques Hacquebord, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Jacques Hacquebord, MD
[email protected]
646-413-9861
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change in Hours Per Day of Prosthesis UseBaseline, Month 1, Month 3, Month 6

    Participants provide their average hours per day of prosthesis use over the past 7 days.

  • Change in Days Per Week of Prosthesis UseBaseline, Month 1, Month 3, Month 6

    Participants provide their average number of days of prosthesis use over the past 7 days.

  • Change in Prosthesis Function LevelBaseline, Month 1, Month 3, Month 6

    Participants rate their current level of function with their prosthesis on a scale from 1 (extremely low) to 10 (extremely high).

  • Change in Prosthesis Satisfaction LevelBaseline, Month 1, Month 3, Month 6

    Participants rate their current level of satisfaction with their prosthesis on a scale from 1 (extremely dissatisfied) to 10 (extremely satisfied).

  • Change in Locomotor Capabilities Index (LCI-5) ScoreBaseline, Month 1, Month 3, Month 6

    14-item assessment of locomotor capabilities; each item is rated on a 5-point scale from 0 to 4; the total score is the sum of responses and ranges from 0-56; higher scores indicate greater locomotor capabilities.