Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System

Status:	Completed
Conditions:	Psychiatric
Therapuetic Areas:	Psychiatry / Psychology
Healthy:	No
Age Range:	18 - Any
Updated:	3/23/2019
Start Date:	October 2013
End Date:	January 28, 2019

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

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).

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

We found this trial at

sites

Denver Clinic for Extremities at Risk

Denver, Colorado 80218

Principal Investigator: Giancarlo Barolat, MD

Phone: 303-928-8855

from

Denver, CO