NCT01996254

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: SPR Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post-Amputation Pain
• Phantom Limb Pain
• Residual Limb Pain

Interventions

Type	Name	Description
DEVICE	SPRINT Peripheral Nerve Stimulation (PNS) System	The SPRINT System is an Investigational Device which 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).

Timeline

• Start date: 2013-10-01
• Primary completion: 2019-01-28
• Completion: 2019-01-28
• First posted: 2013-11-27
• Last updated: 2020-03-26
• Results posted: 2020-03-26

Locations

10 sites across 1 country: United States