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

SPR Therapeutics

Status: Completed

Conditions: Residual Limb Pain; Phantom Limb Pain; Post-Amputation Pain

Treatments: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT01996254

0123-CSP-000

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

28 participants in 2 patient groups

SPRINT Group 1

Experimental group

Description:

Subjects in Group 1 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and will receive electrical stimulation for 8 weeks.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System

SPRINT Group 2

Sham Comparator group

Description:

Subjects in Group 2 will have a Lead placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System for a total of 8 weeks. They will receive 4 weeks of stimulation and 4 weeks with no stimulation.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System