Electrical Nerve Block for Amputation Pain

N/AActive Not RecruitingNCT02221934

Neuros Medical, Inc.607 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

607

Conditions

Post-Amputation Pain Phantom Limb Pain Residual Limb Pain Stump Pain

Interventions

AltiusDEVICE

Electrical signal

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (22)

Arizona Pain Institute

Scottsdale, Arizona, United States

Outcomes

Primary Outcomes

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).

Time frame: Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)

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.

Time frame: From screening injection visit through 3 months post implant

Secondary Outcomes

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

Time frame: 12 months post implant

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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