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Cervicogenic HeadacheNCT05491915

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

A study testing SPRINT Peripheral Nerve Stimulation (PNS) System in people with Cervicogenic Headache and Occipital Neuralgia, run by SPR Therapeutics, Inc. at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervicogenic Headache, Occipital Neuralgia
What is being tested?
SPRINT Peripheral Nerve Stimulation (PNS) System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
10 sitesUnited States
Study dates
24 Oct 2022to Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Pain Specialists of America - South Austin - James Casey

    Austin, Texas, 78745

  • Pain Specialists of America - Cedar Park

    Cedar Park, Texas, 78613

  • Institute of Precision Pain Medicine

    Corpus Christi, Texas, 78414

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • Pain Specialists of America - Round Rock

    Round Rock, Texas, 78681

  • University of Utah

    Salt Lake City, Utah, 84108

  • Pain Specialists of America - San Marcos

    San Marcos, Texas, 78666

  • Pacific Research Institute

    Santa Rosa, California, 95403

  • MedVadis Research

    Waltham, Massachusetts, 02451

  • Center of Clinical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Being tested
SPRINT Peripheral Nerve Stimulation (PNS) System
Keywords
Electrical Stimulation, Neuromodulation, Head pain, Headache, Neck pain
Medical subject headings
Post-Traumatic Headache, Headache, Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPRINT Peripheral Nerve Stimulation (PNS) SystemDevice

    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).

Study groups in NCT05491915
Study groupRoleWhat they receive
Peripheral Nerve StimulationExperimentalAll 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.
Receives: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: During the Lead Placement procedure (SOT)

  3. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 24-48 hours post-SOT

  4. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 1-week post-SOT

  5. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 2-weeks post-SOT

  6. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 3-weeks post-SOT

  7. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 4-weeks post-SOT

  8. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 5-weeks post-SOT

  9. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 6-weeks post-SOT

  10. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 7-weeks post-SOT

  11. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 8-weeks post-SOT

  12. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 3-months post-SOT

  13. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 6-months post-SOT

  14. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 9-months post-SOT

  15. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 12-months post-SOT

  16. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 18-months post-SOT

  17. Study-Related Adverse Events (AEs)

    Occurrence and type of study-related AEs

    Measured: 24-months post-SOT

Secondary outcomes (3)

  1. Reduction in average pain intensity

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

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

  2. Reduction in pain interference

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

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

  3. Reduction in pain medication usage

    Analgesic medication consumption will be collected.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2022
  2. Study start24 Oct 2022
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05491915
Sponsor's protocol ID
0156-CSP-000
Status last verified
Jun 2026
First submitted
4 Aug 2022
Last updated
8 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 40391557

Questions about this trial

What is this clinical trial studying?

A study testing SPRINT Peripheral Nerve Stimulation (PNS) System in people with Cervicogenic Headache and Occipital Neuralgia, run by SPR Therapeutics, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in average pain and/or reduction in pain interference. (time frame: Up to 8-weeks after Start of Therapy (SOT)). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05491915, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.

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Clinical Trial NCT05491915 | AzTrials