The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain

SPR Therapeutics

Status: Enrolling

Conditions: Occipital Neuralgia; Cervicogenic Headache

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05491915

0156-CSP-000

Details and patient eligibility

About

The purpose of this study is to learn if pain can be relieved by delivering small amounts of electricity (called "electrical stimulation") to the nerves at the top of the neck. This study will use a device called the SPRINT® PNS System. PNS stands for peripheral nerve stimulation (PNS). This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Diagnosed cervicogenic headache (CGH) or occipital neuralgia (ON)

Key Exclusion Criteria:

• Uncontrolled Diabetes mellitus Type I or II
• Prior cervical or cranial occipital surgery
• Implanted electronic device (dependent on implant's intended treatment, location, and electrical current pathway)
• Pregnant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Peripheral Nerve Stimulation

Experimental group

Description:

All study subjects will have up to 2 leads placed in the back of their neck, will use the SPRINT Peripheral Nerve Stimulation (PNS) System, and will receive electrical stimulation.

Treatment:

Device: SPRINT Peripheral Nerve Stimulation (PNS) System