Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07571239
Status
Not Yet Recruiting

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Conditions

  • Amputation; Lower Extremity
  • Pain, Persistent Postsurgical

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 1, 2026
Status verified
Apr 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Adult Lower Extremity (LE) Amputees
    Adult LE amputees with chronic/intractable pain despite previous TMR and/or RPNI surgery.

Primary Outcome Measure

Change in Hours Per Day of Prosthesis Use [ Time Frame: Baseline, Month 1, Month 3, Month 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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NYU Langone Health· New York, NY