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Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI

30. april 2026 oppdatert av: NYU Langone Health

A Single-Center, Prospective, Within-Subject Study of Altius® Direct Electrical Nerve Stimulation System in Lower Extremity Amputees With Persistent Pain After Targeted Muscle Reinnervation (TMR) and/or Regenerative Peripheral Nerve Interface (RPNI)

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

32

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • New York
      • New York, New York, Forente stater, 10016
        • NYU Langone Health

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Adult Lower Extremity (LE) Amputees
Adult LE amputees with chronic/intractable pain despite previous TMR and/or RPNI surgery.
Enhet: Surgical Implantation
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.
Andre navn:
  • Altius® Direct Electrical Nerve Stimulation System

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Hours Per Day of Prosthesis Use
Tidsramme: Baseline, Month 1, Month 3, Month 6
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
Tidsramme: Baseline, Month 1, Month 3, Month 6
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
Tidsramme: Baseline, 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).
Baseline, Month 1, Month 3, Month 6
Change in Prosthesis Satisfaction Level
Tidsramme: Baseline, 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).
Baseline, Month 1, Month 3, Month 6
Change in Locomotor Capabilities Index (LCI-5) Score
Tidsramme: Baseline, 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.
Baseline, Month 1, Month 3, Month 6

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Tidsramme: Baseline, Month 1, Month 3, Month 6
9-item assessment of depressive symptoms; each item is rated on a scale from 0-3; the total score is the sum of responses and ranges from 0-27; higher scores indicate greater severity of depressive symptoms.
Baseline, Month 1, Month 3, Month 6
Change in Visual Analogue Score (VAS) - Residual Pain
Tidsramme: Baseline, Month 1, Month 3, Month 6
Residual pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain).
Baseline, Month 1, Month 3, Month 6
Change in Visual Analogue Score (VAS) - Phantom Pain
Tidsramme: Baseline, Month 1, Month 3, Month 6
Phantom pain will be rated on a VAS scale ranging from 0 (no pain) to 10 (worst possible pain).
Baseline, Month 1, Month 3, Month 6
Change in PROMIS Pain Intensity Short Form 8a Score
Tidsramme: Baseline, Month 1, Month 3, Month 6
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Short Form 8a is an 8-item assessment of pain interference in daily life. Each item is rated on a scale from 1 (not at all) to 5 (very much). The raw score is the sum of responses; the raw score is converted to a standardized score ranging from 0-100 with a mean of 50; higher scores indicate more pain interference.
Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Opioids/Narcotics for Pain
Tidsramme: Baseline, Month 1, Month 3, Month 6
Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Medication for Nerve Pain
Tidsramme: Baseline, Month 1, Month 3, Month 6
Baseline, Month 1, Month 3, Month 6
Number of Participants Taking Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Pain
Tidsramme: Baseline, Month 1, Month 3, Month 6
Baseline, Month 1, Month 3, Month 6

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

NYU Langone Health

Etterforskere

  • Hovedetterforsker: Jacques Hacquebord, MD, NYU Langone Health

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

1. juli 2028

Studiet fullført (Antatt)

1. juli 2028

Datoer for studieregistrering

Først innsendt

30. april 2026

Først innsendt som oppfylte QC-kriteriene

30. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 26-00331

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Nei

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