Electrical Nerve Block for Amputation Pain

Not Applicable

Active, not recruiting

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

Interventions: Device: Altius

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.

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

Arm && Interventions

Group	Intervention	Description
Active Sham Control Treatment	Altius	Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
Test Treatment	Altius	Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.

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) 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 Days Per Week	12 months post implant	Average number of pain days 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 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 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.
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.

Trial Locations

Locations (22): Cleveland Clinic Pain Management
🇺🇸
Cleveland, Ohio, United States
University of Illinois Chicago
🇺🇸
Chicago, Illinois, United States
Advanced Surgical and Research Solutions
🇺🇸
Oklahoma City, Oklahoma, United States
Legacy Brain & Spine LLC
🇺🇸
Atlanta, Georgia, United States
Drug Studies America
🇺🇸
Marietta, Georgia, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, 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
Ochsner Clinic Foundation
🇺🇸
New Orleans, Louisiana, United States
Kettering Medical Center
🇺🇸
Springboro, Ohio, United States
The Surgical Clinic
🇺🇸
Nashville, Tennessee, United States
Baylor Scott and White Research Institute
🇺🇸
Dallas, Texas, United States
Baylor Scott and White - Temple Memorial Vascular Surgery
🇺🇸
Temple, Texas, United States
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Cardiovascular Surgery Clinic
🇺🇸
Memphis, Tennessee, United States
Arizona Pain Institute
🇺🇸
Scottsdale, Arizona, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Center for Clinical Research
🇺🇸
Winston-Salem, North Carolina, United States
Nona Medical Arts
🇺🇸
Orlando, Florida, United States
Meta Medical Research Institute
🇺🇸
Dayton, Ohio, United States
Emory University / Grady Hospital
🇺🇸
Atlanta, Georgia, United States