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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
Must not have
Spasticity preventing full range of motion of involved side
Subjects with active local or systemic infection or immunocompromised
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomized testing window (month-1 to month-3 post implant, 2 month duration)
Awards & highlights

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My spasticity stops me from moving fully.
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I have an active infection or a weakened immune system.
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My amputated limb has a very short remaining part.
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My diabetes is not under control.
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My neurological condition, like multiple sclerosis, is getting worse.
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I have another source of pain that could affect my ability to report limb pain accurately.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomized testing window (month-1 to month-3 post implant, 2 month duration)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomized testing window (month-1 to month-3 post implant, 2 month duration) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Effectiveness Endpoint: Reduction of Pain Level by 50% From Baseline
Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events
Secondary study objectives
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 more
Other study objectives
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

Altius System (Electrical Nerve Block) Clinical Trial Eligibility Overview. Trial Name: NCT02221934 — N/A
Post-Amputation Pain Research Study Groups: Test Treatment, Active Sham Control Treatment
Post-Amputation Pain Clinical Trial 2023: Altius System Highlights & Side Effects. Trial Name: NCT02221934 — N/A
Altius System (Electrical Nerve Block) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02221934 — N/A
~56 spots leftby Oct 2025