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Electrical Nerve Block
Electrical Nerve Block for Phantom Limb Pain
N/A
Waitlist Available
Led By Leonardo Kapural, MD, PhD
Research Sponsored by Neuros Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Unilateral amputated leg ≥ 12 months
Age ≥ 21 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomized testing window (month-1 to month-3 post implant, 2 month duration)
Awards & highlights
Study Summary
This trial is to see if a new pain treatment is safe and effective for people who have had an amputation.
Who is the study for?
This trial is for adults over 21 with chronic pain after leg amputation, lasting at least 6 months. Candidates must have had their limb amputated for over a year and be on a stable medication regimen without changes to medications or prosthesis planned during the study. Exclusions include those needing MRI post-implant, with active medical devices like pacemakers, untreated major psychological issues, life expectancy under two years, other major pain sources or conditions like uncontrolled diabetes.Check my eligibility
What is being tested?
The trial is testing the Altius System's electrical nerve block to see if it safely and effectively reduces pain in patients who have undergone an amputation. Participants will receive this non-drug treatment aimed at managing long-term post-amputation pain.See study design
What are the potential side effects?
Potential side effects of the Altius System may include discomfort at the site of application, skin irritation from electrodes, possible nerve damage if not properly administered, and muscle twitching due to electrical stimulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had one leg amputated over a year ago.
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I am 21 years old or older.
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My pain episodes usually last an hour or more.
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I have had pain for over 6 months after an amputation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomized testing window (month-1 to month-3 post implant, 2 month duration)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomized testing window (month-1 to month-3 post implant, 2 month duration)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
Secondary outcome measures
Secondary Effectiveness: Health-related Quality of Life (HR-QOL)
Secondary Effectiveness: Pain Days Per Week
Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL
+4 moreOther outcome measures
Exploratory Efficacy: Prosthetic Use
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Test TreatmentExperimental Treatment1 Intervention
Self-initiated high frequency bioelectric nerve block delivered to the nerve by Altius.
Group II: Active Sham Control TreatmentActive Control1 Intervention
Self-initiated non-therapeutic electrical signal delivered to the nerve by Altius.
Find a Location
Who is running the clinical trial?
Neuros Medical, Inc.Lead Sponsor
Leonardo Kapural, MD, PhDPrincipal InvestigatorCenter for Clinical Research, Winston-Salem NC
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My spasticity stops me from moving fully.I have an active infection or a weakened immune system.You are not expected to live for more than 2 years.I had one leg amputated over a year ago.I am 21 years old or older.My pain episodes usually last an hour or more.My amputated limb has a very short remaining part.My medication has not changed in the last 4 weeks.You have a mental health condition that has not been treated yet.My diabetes is not under control.I have had pain for over 6 months after an amputation.My neurological condition, like multiple sclerosis, is getting worse.I have another source of pain that could affect my ability to report limb pain accurately.
Research Study Groups:
This trial has the following groups:- Group 1: Active Sham Control Treatment
- Group 2: Test Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals has this research endeavor set out to accomplish?
"The anticipated duration of this trial is three months post-implant. The primary safety endpoint will be the incidence of serious adverse events as reported and adjudicated. Secondary endpoints include average number of pain days compared to baseline at 3, 6, and 12 months; percent change in intensity from before treatment up until two hours after treatment; and quality of life measured through EQ-5D summary index, SF-12 physical component score, and mental component score considered relative to baseline values."
Answered by AI
To what extent has this trial been implemented in medical facilities?
"Currently, patients can enroll in this research trial at University of Arkansas for Medical Sciences (UAMS) located in Little Rock, the Cleveland Clinic Pain management facility found within Ohio's borders and the University of Washington Medical Center situated near Seattle. Moreover, nineteen other locations are open to potential participants."
Answered by AI
Are there still opportunities for enrolment in this experiment?
"This clinical trial, posted on October 9th 2014 and last updated November 18th 2022, is no longer recruiting patients. However, there are 27 other medical studies with open enrollment at the present time."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
Texas
How old are they?
18 - 65
What site did they apply to?
The Surgical Clinic
Baylor Scott and White Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- The Surgical Clinic: < 24 hours
Average response time
- < 1 Day
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