Electrical Nerve Block for Amputation Pain

High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Phantom Limb Pain; Residual Limb Pain; Post-Amputation Pain; Stump Pain
• Intervention / Treatment: Device: Altius

Detailed Description

The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.

• Study Type: Interventional
• Enrollment (Actual): 607
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Arizona Pain Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences (UAMS)
  • Colorado
    • Denver, Colorado, United States, 80218
      • HCA Healthcare Research Institute / St. Luke's Presbyterian
  • Florida
    • Orlando, Florida, United States, 32827
      • Nona Medical Arts
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University / Grady Hospital
    • Atlanta, Georgia, United States, 30339
      • Legacy Brain & Spine LLC
    • Marietta, Georgia, United States, 30060
      • Drug Studies America
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Center for Clinical Research
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Cleveland Clinic Pain Management
    • Dayton, Ohio, United States, 45432
      • META Medical Research Institute
    • Springboro, Ohio, United States, 45066
      • Kettering Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Advanced Surgical and Research Solutions
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Cardiovascular Surgery Clinic
    • Nashville, Tennessee, United States, 37203
      • The Surgical Clinic
  • Texas
    • Dallas, Texas, United States, 75201
      • Baylor Scott and White Research Institute
    • Temple, Texas, United States, 76508
      • Baylor Scott and White - Temple Memorial Vascular Surgery
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Treatment; Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.	Device: Altius; Electrical signal
Active Comparator: Active Sham Control Treatment; Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.	Device: Altius; Electrical signal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events	Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.	From screening injection visit through 3 months post implant
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline	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).	Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Effectiveness: Pain Medication Use	Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.	12 months post implant
Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL	Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.	12 months post implant
Secondary Effectiveness: Patient Global Impression of Change (PGIC)	Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits	12 months post implant
Secondary Safety	Incidence of all Non-Serious Adverse Events, including Non-Serious Adverse Events, Non-Serious Adverse Device Events, and Unanticipated (Non-Serious) Adverse Device Events from the time of consent through 12 months post implant.	12 months post implant
Secondary Effectiveness: Pain Relief After 2 Hours	Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment	12 months post implant
Secondary Effectiveness: Health-related Quality of Life (HR-QOL)	EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.	12 months post implant

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Efficacy: Prosthetic Use	Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.	12 months post implant

Collaborators and Investigators

• Sponsor: Neuros Medical, Inc.
• Investigators: Principal Investigator: Leonardo Kapural, MD, PhD, Center for Clinical Research, Winston-Salem NC

Publications and helpful links

General Publications

• Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.
• Kapural L, Syed Shah N, Fang ZP, Mekhail N. Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). J Pain Res. 2022 Jun 3;15:1623-1631. doi: 10.2147/JPR.S353674. eCollection 2022.
• Kapural L, Melton J, Kim B, Mehta P, Sigdel A, Bautista A, Petersen EA, Slavin KV, Eidt J, Wu J, Elshihabi S, Schwalb JM, Garrett HE Jr, Veizi E, Barolat G, Rajani RR, Rhee PC, Guirguis M, Mekhail N. Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain. J Pain Res. 2024 Jun 6;17:2001-2014. doi: 10.2147/JPR.S463727. eCollection 2024.
• Kapural L, Kim B, Eidt J, Petersen EA, Schwalb JM, Slavin KV, Mekhail N. Long-Term Treatment of Chronic Postamputation Pain With Bioelectric Nerve Block: Twelve-Month Results of the Randomized, Double-Blinded, Cross-Over QUEST Study. Neuromodulation. 2024 Dec;27(8):1383-1392. doi: 10.1016/j.neurom.2024.08.010. Epub 2024 Sep 24.

Helpful Links

• Neuros HFNB Pilot Study - Abstract
• QUEST 3-month (Primary) RCT Outcomes
• QUEST 12-month (Secondary) Long Term Outcomes
• QUEST Study Design

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2014
• Primary Completion (Actual): December 31, 2021
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 15, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (Estimated): August 21, 2014

Study Record Updates

• Last Update Posted (Actual): June 6, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Chronic; Amputation; Phantom Pain; Stump Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: 003-0001; QUEST Trial (Other Identifier: Neuros Medical)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes