Summary

for people ages 21 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

The purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA for up to 60 days of use for the management of chronic pain, including extremity (leg) pain.

Official Title

The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain in a Randomized, Double-blinded, Placebo-controlled, Multicenter Trial

Keywords

Neuropathic Pain Amputation Neuralgia SPRINT Peripheral Nerve Stimulation (PNS) System

Eligibility

For people ages 21 years and up

Key Inclusion Criteria:

  • At least 21 years old
  • Lower extremity amputation
  • Experiencing residual limb (stump) and/or phantom limb pain
  • Healed amputation and healthy residual limb based upon the investigator's evaluation

Key Exclusion Criteria:

  • Conditions with increased risk of infection (e.g., compromised immune system or history of recurrent skin infections)
  • Implanted electronic device
  • Pregnancy

Locations

  • University of California San Diego not yet accepting patients
    La Jolla California 92093 United States
  • Northwestern University not yet accepting patients
    Chicago Illinois 60611 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SPR Therapeutics, Inc.
ID
NCT03783689
Study Type
Interventional
Last Updated