Electrical Nerve Block for Phantom Limb Pain

Recruiting in Palo Alto (17 mi)

+22 other locations

Overseen ByLeonardo Kapural, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Neuros Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

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.

+3 more

Exclusion 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.

+7 more

Participant Groups

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.

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.