Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02221934

Electrical Nerve Block for Amputation Pain

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Post-Amputation Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Organizing Pneumonia Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Phantom Limb Pain Postoperative Complications Residual Limb Pain Respiratory Tract Diseases Signs and Symptoms Stump Pain

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Pain Institute, Scottsdale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Altius

Device

Electrical signal

Primary outcomes

  1. Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline

    Time frame: 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).

  2. Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events

    Time frame: 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.

Secondary outcomes

  1. Secondary Effectiveness: Pain Relief After 2 Hours

    Time frame: 12 months post implant

    Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment

  2. Secondary Effectiveness: Pain Medication Use

    Time frame: 12 months post implant

    Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.

  3. Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL

    Time frame: 12 months post implant

    Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.

  4. Secondary Effectiveness: Health-related Quality of Life (HR-QOL)

    Time frame: 12 months post implant

    EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.

  5. Secondary Effectiveness: Patient Global Impression of Change (PGIC)

    Time frame: 12 months post implant

    Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits

  6. Secondary Safety

    Time frame: 12 months post implant

    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.

Sponsors and collaborators

Lead sponsor

Neuros Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2025
First posted
Aug 21, 2014
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.