The SNAP Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Neuropathic Post-Amputation Pain

SPR Therapeutics

Status: Terminated

Conditions: Neuropathic Pain; Amputation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03783689

0147-CSP-000

Details and patient eligibility

About

The purpose of this study is to determine if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves in an individual's amputated leg.This study will involve the use of a Peripheral Nerve Stimulation (PNS) System that is made by SPR Therapeutics (the sponsor of the study). The PNS System was cleared by the FDA for up to 60 days of use for the management of chronic pain, including extremity (leg) pain.

Enrollment: 38 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• At least 21 years old
• Lower extremity amputation
• Experiencing residual limb (stump) and/or phantom limb pain
• Healed amputation and healthy residual limb based upon the investigator's evaluation

Key Exclusion Criteria:

• Conditions with increased risk of infection (e.g., compromised immune system or history of recurrent skin infections)
• Implanted electronic device
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Group 1 (Treatment)

Active Comparator group

Description:

Subjects in Group 1 will have Leads 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

Group 2 (Control)

Sham Comparator group

Description:

Subjects in Group 2 will have Leads placed in the residual limb in the upper leg. These subjects will then use the SPRINT Peripheral Nerve Stimulation (PNS) System and receive 8 weeks of sham stimulation. Subjects will then have the option to crossover and receive stimulation therapy.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System