Electrical Nerve Block for Amputation Pain

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: Altius


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline | Demonstration of 50% reduction in a Numerical Rating Scale (NRS) 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) | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: Pain Days Per Week | Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline. | 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. | 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: 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Chronic, Amputation, Phantom Pain, Stump Pain