Electrical Nerve Block for Amputation Pain

NCT02221934 · tracked via the Priya Life Science USA tracker

Sponsor

Neuros Medical, Inc.

Phase

Not applicable

Started

2014-10-09

Last updated

2025-06-06

Condition(s) studied

Post-Amputation PainPhantom Limb PainResidual Limb PainStump Pain

Investigational drug(s) / intervention(s)

Altius

Altius: Electrical signal

Study summary

The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.

Eligibility

Sex

ALL

Min age

21 Years

Max age

—

Healthy volunteers

Key Inclusion Criteria: * Age ≥ 21 years old * Unilateral amputated leg ≥ 12 months * Chronic post amputation pain ≥ 6 months * Pain episodes typically lasting ≥ 60 minutes * Stable drug regimen ≥ 4 weeks * No changes to medications or prosthesis for 3-month primary study period Key Exclusion Criteria: * Implanted with an active implantable medical device (i.e. pacemaker) * Confounding source of pain that interferes with reporting of limb pain * Uncontrolled diabetes * Spasticity preventing full range of motion of involved side * Extremely short stump; sits on end * Untreated psychological condition (i.e. borderline personality) * Condition requiring MRI studies or diathermy after device implant * Life expectancy of less than 24 months * Progressive neurological disease (i.e. multiple sclerosis) * Subjects with active local or systemic infection or immunocompromised

Primary outcome measure(s)

Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline — Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
Demonstration of 50% reduction in a Numerical Rating Scale (NRS; 0-10 Scale; with 10 being the highest pain imaginable) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events — From screening injection visit through 3 months post implant
Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.

Trial sites (22)

Facility	City	Region
Arizona Pain Institute	Scottsdale	Arizona
University of Arkansas for Medical Sciences (UAMS)	Little Rock	Arkansas
HCA Healthcare Research Institute / St. Luke's Presbyterian	Denver	Colorado
Nona Medical Arts	Orlando	Florida
Emory University / Grady Hospital	Atlanta	Georgia
Legacy Brain & Spine LLC	Atlanta	Georgia
Drug Studies America	Marietta	Georgia
University of Illinois Chicago	Chicago	Illinois
University of Louisville	Louisville	Kentucky
Ochsner Clinic Foundation	New Orleans	Louisiana
Henry Ford Health System	Detroit	Michigan
Mayo Clinic	Rochester	Minnesota
Center for Clinical Research	Winston-Salem	North Carolina
Cleveland Clinic Pain Management	Cleveland	Ohio
Meta Medical Research Institute	Dayton	Ohio
Kettering Medical Center	Springboro	Ohio
Advanced Surgical and Research Solutions	Oklahoma City	Oklahoma
Cardiovascular Surgery Clinic	Memphis	Tennessee
The Surgical Clinic	Nashville	Tennessee
Baylor Scott and White Research Institute	Dallas	Texas
Baylor Scott and White - Temple Memorial Vascular Surgery	Temple	Texas
University of Washington Medical Center	Seattle	Washington

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02221934 on ClinicalTrials.gov ↗ ← All trials in the USA