Summary

for people ages 18 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 electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Official Title

A Randomized, Double-Blinded, Placebo-Controlled, Multicenter Pilot Study of the SPRINT Peripheral Nerve Stimulation (PNS) System for the Treatment of Post-Amputation Pain

Keywords

Post-Amputation Pain Phantom Limb Pain Residual Limb Pain electrical stimulation neurostimulation neuromodulation neuropathic pain amputee pain Phantom Limb SPRINT Peripheral Nerve Stimulation (PNS) System

Eligibility

For people ages 18 years and up

Key Inclusion Criteria:

  • At least 18 years old
  • Traumatic lower extremity amputation(s)
  • Healed amputation and healthy residual limb based upon the investigator's evaluation

Key Exclusion Criteria:

  • Change of prescribed medications affecting pain within the past 4 weeks
  • Compromised immune system based on medical history
  • Implanted electronic device
  • Bleeding disorder
  • History of valvular heart disease
  • Confounding central nervous system injuries and disorders
  • History of recurrent skin infections

Locations

  • University of California San Diego
    La Jolla California 92093 United States
  • Arizona Pain
    Scottsdale Arizona 85258 United States
  • Denver Clinic for Extremities at Risk
    Denver Colorado 80218 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SPR Therapeutics, Inc.
Links
Sponsor's Website
Collaborator's Website
ID
NCT01996254
Study Type
Interventional
Last Updated
August 6, 2018