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

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