Clinical trial NCT02221934: Electrical Nerve Block for Amputation Pain
Official title: High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post-Amputation Pain
Phantom Limb Pain
Residual Limb Pain
Stump Pain
Keywords: Pain
Chronic
Amputation
Phantom Pain
Stump Pain
Lead sponsor: Neuros Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-21
Enrollment: 607
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
timeFrame: Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
measure: Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
timeFrame: From screening injection visit through 3 months post implant
Secondary outcomes:
measure: Secondary Effectiveness: Pain Relief After 2 Hours
timeFrame: 12 months post implant
measure: Secondary Effectiveness: Pain Medication Use
timeFrame: 12 months post implant
measure: Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL
timeFrame: 12 months post implant
measure: Secondary Effectiveness: Health-related Quality of Life (HR-QOL)
timeFrame: 12 months post implant
measure: Secondary Effectiveness: Patient Global Impression of Change (PGIC)
timeFrame: 12 months post implant
measure: Secondary Safety
timeFrame: 12 months post implant
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Pain Institute
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences (UAMS)
state: Arkansas
city: Denver
country: United States
facility: HCA Healthcare Research Institute / St. Luke's Presbyterian
state: Colorado
city: Orlando
country: United States
facility: Nona Medical Arts
state: Florida
city: Atlanta
country: United States
facility: Emory University / Grady Hospital
state: Georgia
city: Atlanta
country: United States
facility: Legacy Brain & Spine LLC
state: Georgia
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Chicago
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Pain Management
state: Ohio
city: Dayton
country: United States
facility: Meta Medical Research Institute
state: Ohio
city: Springboro
country: United States
facility: Kettering Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Advanced Surgical and Research Solutions
state: Oklahoma
city: Memphis
country: United States
facility: Cardiovascular Surgery Clinic
state: Tennessee
city: Nashville
country: United States
facility: The Surgical Clinic
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Temple
country: United States
facility: Baylor Scott and White - Temple Memorial Vascular Surgery
state: Texas
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: Center for Clinical Research, Winston-Salem NC
name: Leonardo Kapural, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.
citation: Kapural L, Syed Shah N, Fang ZP, Mekhail N. Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). J Pain Res. 2022 Jun 3;15:1623-1631. doi: 10.2147/JPR.S353674. eCollection 2022.
citation: Kapural L, Melton J, Kim B, Mehta P, Sigdel A, Bautista A, Petersen EA, Slavin KV, Eidt J, Wu J, Elshihabi S, Schwalb JM, Garrett HE Jr, Veizi E, Barolat G, Rajani RR, Rhee PC, Guirguis M, Mekhail N. Primary 3-Month Outcomes of a Double-Blind Randomized Prospective Study (The QUEST Study) Assessing Effectiveness and Safety of Novel High-Frequency Electric Nerve Block System for Treatment of Post-Amputation Pain. J Pain Res. 2024 Jun 6;17:2001-2014. doi: 10.2147/JPR.S463727. eCollection 2024.
citation: Kapural L, Kim B, Eidt J, Petersen EA, Schwalb JM, Slavin KV, Mekhail N. Long-Term Treatment of Chronic Postamputation Pain With Bioelectric Nerve Block: Twelve-Month Results of the Randomized, Double-Blinded, Cross-Over QUEST Study. Neuromodulation. 2024 Dec;27(8):1383-1392. doi: 10.1016/j.neurom.2024.08.010. Epub 2024 Sep 24.