Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI

NCT07571239 | Not Yet Recruiting FDA Device

• 1 other identifier: 26-00331
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, within-subject study. This study seeks to enroll a total of 32 prospective subjects who will undergo surgical implantation of the FDA-approved Altius® system. Subjects will be followed longitudinally and will complete a series of patient-reported outcome measure questionnaires, a study intake questionnaire which assesses demographics, amputation and prosthesis history, and medical/medication history.

Conditions

Amputation; Lower Extremity; Pain, Persistent Postsurgical

Outcome Measures

Primary Outcomes (5)

• Change in Hours Per Day of Prosthesis Use

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

  Baseline, Month 1, Month 3, Month 6

• Change in Days Per Week of Prosthesis Use

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

  Baseline, Month 1, Month 3, Month 6

• Change in Prosthesis Function Level

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

  Baseline, Month 1, Month 3, Month 6

• Change in Prosthesis Satisfaction Level

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

  Baseline, Month 1, Month 3, Month 6

• Change in Locomotor Capabilities Index (LCI-5) Score

  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.

  Baseline, Month 1, Month 3, Month 6

Secondary Outcomes (7)

• Change in Patient Health Questionnaire-9 (PHQ-9) Score

  Baseline, Month 1, Month 3, Month 6

• Change in Visual Analogue Score (VAS) - Residual Pain

  Baseline, Month 1, Month 3, Month 6

• Change in Visual Analogue Score (VAS) - Phantom Pain

  Baseline, Month 1, Month 3, Month 6

• Change in PROMIS Pain Intensity Short Form 8a Score

  Baseline, Month 1, Month 3, Month 6

• Number of Participants Taking Opioids/Narcotics for Pain

  Baseline, Month 1, Month 3, Month 6

Study Arms (1)

Adult Lower Extremity (LE) Amputees

EXPERIMENTAL

Adult LE amputees with chronic/intractable pain despite previous TMR and/or RPNI surgery.

Device: Surgical Implantation

Interventions

Surgical Implantation DEVICE

The Altius system will be surgically implanted into the patient on one occasion. The Altius system is then used on an 'as needed' basis by patient.

Also known as: Altius® Direct Electrical Nerve Stimulation System

Adult Lower Extremity (LE) Amputees

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• % or greater pain reduction after receiving SOC ultrasound-guided lidocaine injection
• Able and willing to provide consent

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jacques Hacquebord, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Hacquebord, MD

CONTACT

646-413-9861; Jacques.Hacquebord@nyulangone.org

Anne Genzelev

CONTACT

617-835-8018; Anne.genzelev@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)