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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cervicogenic Headache; Occipital Neuralgia
• Intervention / Treatment: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Rosa, California, United States, 95403
      • Pacific Research Institute
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • MedVadis Research
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Rochester
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Center of Clinical Research
  • Texas
    • Austin, Texas, United States, 78745
      • Pain Specialists of America - South Austin - James Casey
    • Cedar Park, Texas, United States, 78613
      • Pain Specialists of America - Cedar Park
    • Corpus Christi, Texas, United States, 78414
      • Institute of Precision Pain Medicine
    • Round Rock, Texas, United States, 78681
      • Pain Specialists of America - Round Rock
    • San Marcos, Texas, United States, 78666
      • Pain Specialists of America - San Marcos
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peripheral Nerve Stimulation; 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.	Device: SPRINT Peripheral Nerve Stimulation (PNS) System; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in average pain and/or reduction in pain interference.	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.	Up to 8-weeks after Start of Therapy (SOT)
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	During the Lead Placement procedure (SOT)
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	24-48 hours post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	1-week post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	2-weeks post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	3-weeks post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	4-weeks post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	5-weeks post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	6-weeks post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	7-weeks post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	8-weeks post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	3-months post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	6-months post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	9-months post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	12-months post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	18-months post-SOT
Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	24-months post-SOT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in average pain intensity	Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form.	Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT
Reduction in pain interference	Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form.	Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT
Reduction in pain medication usage	Analgesic medication consumption will be collected.	Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT

Collaborators and Investigators

• Sponsor: SPR Therapeutics, Inc.

Publications and helpful links

General Publications

• Gutierrez GG, McCormick ZL, Engle MP, Gilmore CA, Pingree MJ, Pope JE, DiBenedetto DJ, Kissoon NR, Sayal PK, Zurn CA, Crosby ND, Boggs JW. A multicenter, prospective, single-arm study of 60-day peripheral nerve stimulation of the occipital nerves for the treatment of headache. Headache. 2025 Nov-Dec;65(10):1776-1787. doi: 10.1111/head.14948. Epub 2025 May 20.

Helpful Links

• Sponsor's Website

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 4, 2022
• First Submitted That Met QC Criteria: August 4, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): June 8, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Neuromodulation; Headache; Electrical Stimulation; Neck pain; Head pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Headache; Neck Pain; Post-Traumatic Headache; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: 0156-CSP-000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No