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

Last updated: June 9, 2025
Sponsor: SPR Therapeutics, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Neuropathic Facial Pain

Neck Pain

Oral Facial Pain

Treatment

SPRINT Peripheral Nerve Stimulation (PNS) System

Clinical Study ID

NCT05491915
0156-CSP-000
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

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

Exclusion

Key Exclusion Criteria:

  • Prior cervical or cranial occipital surgery

  • Implanted electronic device (dependent on implant's intended treatment, location,and electrical current pathway)

  • Pregnant

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: SPRINT Peripheral Nerve Stimulation (PNS) System
Phase:
Study Start date:
October 24, 2022
Estimated Completion Date:
August 31, 2027

Connect with a study center

  • Pacific Research Institute

    Santa Rosa, California 95403
    United States

    Site Not Available

  • MedVadis Research

    Waltham, Massachusetts 02451
    United States

    Site Not Available

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Center of Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Pain Specialists of America - South Austin - James Casey

    Austin, Texas 78745
    United States

    Site Not Available

  • Pain Specialists of America - Cedar Park

    Cedar Park, Texas 78613
    United States

    Site Not Available

  • Institute of Precision Pain Medicine

    Corpus Christi, Texas 78414
    United States

    Site Not Available

  • Pain Specialists of America - Round Rock

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Pain Specialists of America - San Marcos

    San Marcos, Texas 78666
    United States

    Site Not Available

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Site Not Available

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