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Electrical Nerve Block for Amputation Pain

Primary Purpose

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

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Altius
Sponsored by
Neuros Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Amputation Pain focused on measuring Pain, Chronic, Amputation, Phantom Pain, Stump Pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona Pain Institute
  • University of Arkansas for Medical Sciences (UAMS)
  • HCA Healthcare Research Institute / St. Luke's Presbyterian
  • Nona Medical Arts
  • Emory University / Grady Hospital
  • Legacy Brain & Spine LLC
  • Drug Studies America
  • University of Illinois Chicago
  • University of Louisville
  • Ochsner Clinic Foundation
  • Henry Ford Health System
  • Mayo Clinic
  • Center for Clinical Research
  • Cleveland Clinic Pain Management
  • Meta Medical Research Institute
  • Kettering Medical Center
  • Advanced Surgical and Research Solutions
  • Cardiovascular Surgery Clinic
  • The Surgical Clinic
  • Baylor Scott and White Research Institute
  • Baylor Scott and White - Temple Memorial Vascular Surgery
  • University of Washington Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Treatment

Active Sham Control Treatment

Arm Description

Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.

Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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
Secondary Effectiveness: Pain Days Per Week
Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline.
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.
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.
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.
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
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.

Full Information

First Posted
August 15, 2014
Last Updated
August 17, 2023
Sponsor
Neuros Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02221934
Brief Title
Electrical Nerve Block for Amputation Pain
Official Title
High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 9, 2014 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuros Medical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Amputation Pain, Phantom Limb Pain, Residual Limb Pain, Stump Pain
Keywords
Pain, Chronic, Amputation, Phantom Pain, Stump Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
607 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Treatment
Arm Type
Experimental
Arm Description
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
Arm Title
Active Sham Control Treatment
Arm Type
Active Comparator
Arm Description
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
Intervention Type
Device
Intervention Name(s)
Altius
Intervention Description
Electrical signal
Primary Outcome Measure Information:
Title
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
Description
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).
Time Frame
Randomized Testing Window (Month-1 to Month-3 post implant, 2 Month duration)
Title
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
Description
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 Outcome Measure Information:
Title
Secondary Effectiveness: Pain Relief After 2 Hours
Description
Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment
Time Frame
12 months post implant
Title
Secondary Effectiveness: Pain Days Per Week
Description
Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline.
Time Frame
12 months post implant
Title
Secondary Effectiveness: Pain Medication Use
Description
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
Title
Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL
Description
Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.
Time Frame
12 months post implant
Title
Secondary Effectiveness: Health-related Quality of Life (HR-QOL)
Description
EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.
Time Frame
12 months post implant
Title
Secondary Effectiveness: Patient Global Impression of Change (PGIC)
Description
Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits
Time Frame
12 months post implant
Title
Secondary Safety
Description
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.
Time Frame
12 months post implant
Other Pre-specified Outcome Measures:
Title
Exploratory Efficacy: Prosthetic Use
Description
Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
Time Frame
12 months post implant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonardo Kapural, MD, PhD
Organizational Affiliation
Center for Clinical Research, Winston-Salem NC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Pain Institute
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
University of Arkansas for Medical Sciences (UAMS)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
HCA Healthcare Research Institute / St. Luke's Presbyterian
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Nona Medical Arts
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Emory University / Grady Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Legacy Brain & Spine LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
Drug Studies America
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University of Illinois Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Center for Clinical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cleveland Clinic Pain Management
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Meta Medical Research Institute
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Kettering Medical Center
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Facility Name
Advanced Surgical and Research Solutions
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73134
Country
United States
Facility Name
Cardiovascular Surgery Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
The Surgical Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Scott and White Research Institute
City
Dallas
State/Province
Texas
ZIP/Postal Code
75201
Country
United States
Facility Name
Baylor Scott and White - Temple Memorial Vascular Surgery
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25655583
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.
Results Reference
background
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/25655583
Description
Neuros HFNB Pilot Study - Abstract

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Electrical Nerve Block for Amputation Pain

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