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NCT Number: NCT05491915

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cervicogenic Headache Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Secondary Neck Pain Nervous System Diseases Neurologic Manifestations Occipital Neuralgia Pain Pathological Conditions, Signs and Symptoms Post-Traumatic Headache Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pacific Research Institute, Santa Rosa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Treatment and study plan

SPRINT Peripheral Nerve Stimulation (PNS) System

Device

The SPRINT System delivers mild electrical stimulation to the occipital nerves. The SPRINT System includes up to two leads (small wires) that are placed through your skin at the top of your neck. The leads attach to devices worn on your body that deliver stimulation (called Stimulators).

Primary outcomes

  1. Reduction in average pain and/or reduction in pain interference.

    Time frame: Up to 8-weeks after Start of Therapy (SOT)

    Average pain is measured using question 5 from the Brief Pain Inventory-Short Form (BPI-5) and pain interference is measured using question 9 from the Brief Pain Inventory-Short Form (BPI-9). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain. BPI-9 is a scale of 0 to 10 where 0 represents no interference and 10 represents complete interference.

  2. Study-Related Adverse Events (AEs)

    Time frame: During the Lead Placement procedure (SOT)

    Occurrence and type of study-related AEs

  3. Study-Related Adverse Events (AEs)

    Time frame: 24-48 hours post-SOT

    Occurrence and type of study-related AEs

  4. Study-Related Adverse Events (AEs)

    Time frame: 1-week post-SOT

    Occurrence and type of study-related AEs

  5. Study-Related Adverse Events (AEs)

    Time frame: 2-weeks post-SOT

    Occurrence and type of study-related AEs

  6. Study-Related Adverse Events (AEs)

    Time frame: 3-weeks post-SOT

    Occurrence and type of study-related AEs

  7. Study-Related Adverse Events (AEs)

    Time frame: 4-weeks post-SOT

    Occurrence and type of study-related AEs

  8. Study-Related Adverse Events (AEs)

    Time frame: 5-weeks post-SOT

    Occurrence and type of study-related AEs

  9. Study-Related Adverse Events (AEs)

    Time frame: 6-weeks post-SOT

    Occurrence and type of study-related AEs

  10. Study-Related Adverse Events (AEs)

    Time frame: 7-weeks post-SOT

    Occurrence and type of study-related AEs

  11. Study-Related Adverse Events (AEs)

    Time frame: 8-weeks post-SOT

    Occurrence and type of study-related AEs

  12. Study-Related Adverse Events (AEs)

    Time frame: 3-months post-SOT

    Occurrence and type of study-related AEs

  13. Study-Related Adverse Events (AEs)

    Time frame: 6-months post-SOT

    Occurrence and type of study-related AEs

  14. Study-Related Adverse Events (AEs)

    Time frame: 9-months post-SOT

    Occurrence and type of study-related AEs

  15. Study-Related Adverse Events (AEs)

    Time frame: 12-months post-SOT

    Occurrence and type of study-related AEs

  16. Study-Related Adverse Events (AEs)

    Time frame: 18-months post-SOT

    Occurrence and type of study-related AEs

  17. Study-Related Adverse Events (AEs)

    Time frame: 24-months post-SOT

    Occurrence and type of study-related AEs

Secondary outcomes

  1. Reduction in average pain intensity

    Time frame: Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT

    Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form.

  2. Reduction in pain interference

    Time frame: Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT

    Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form.

  3. Reduction in pain medication usage

    Time frame: Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT

    Analgesic medication consumption will be collected.

Sponsors and collaborators

Lead sponsor

SPR Therapeutics, Inc.

Industry

Registry information

Official study title

The MONARCH (Multicenter Occipital Neuralgia and Cervicogenic Headache) Case Series Study: Treatment of Head Pain With the SPRINT® Peripheral Nerve Stimulation (PNS) System

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Aug 8, 2022
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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