Electrical Nerve Block for Amputation Pain

Not Applicable

Active, not recruiting

• Conditions: Phantom Limb Pain; Residual Limb Pain; Stump Pain; Post-Amputation Pain

• Registration Number: NCT02221934
• Lead Sponsor: Neuros Medical, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2014-08-15
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-21
• Study Start: 2014-10-09
• Primary Completion: 2021-12-31
• Results First Submitted: 2023-06-27
• Results First Submitted QC: 2023-08-17
• Results First Posted: 2023-09-11
• Status Verified: 2024-10
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-06-06
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 607

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Secondary Effectiveness: Pain Relief After 2 Hours	12 months post implant	Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment
Secondary Effectiveness: Pain Medication Use	12 months post implant	Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL	12 months post implant	Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.
Secondary Effectiveness: Health-related Quality of Life (HR-QOL)	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.
Secondary Effectiveness: Patient Global Impression of Change (PGIC)	12 months post implant	Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits
Secondary Safety	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.

Trial Locations

Locations (22)

Arizona Pain Institute; 🇺🇸 Scottsdale, Arizona, United States

University of Arkansas for Medical Sciences (UAMS); 🇺🇸 Little Rock, Arkansas, United States

HCA Healthcare Research Institute / St. Luke's Presbyterian; 🇺🇸 Denver, Colorado, United States

Nona Medical Arts; 🇺🇸 Orlando, Florida, United States

Emory University / Grady Hospital; 🇺🇸 Atlanta, Georgia, United States

Legacy Brain & Spine LLC; 🇺🇸 Atlanta, Georgia, United States

Drug Studies America; 🇺🇸 Marietta, Georgia, United States

University of Illinois Chicago; 🇺🇸 Chicago, Illinois, United States

University of Louisville; 🇺🇸 Louisville, Kentucky, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

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