This study is in progress, not accepting new patients

The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain

a study on Neuropathic Pain Amputation

Summary

Eligibility
for people ages 21 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
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

You can join if…

Open to people ages 21 years and up

  • 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

You CAN'T join if...

  • 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
    La Jolla California 92093 United States
  • Pain Center of Arizona - Hope Research Institute
    Phoenix Arizona 85018 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SPR Therapeutics, Inc.
ID
NCT03783689
Study Type
Interventional
Participants
Expecting 126 study participants
Last Updated