The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain
NCT ID: NCT05491915
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2022-10-24
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Implanted electronic device (dependent on implant's intended treatment, location, and electrical current pathway)
* Pregnant
18 Years
ALL
No
Sponsors
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SPR Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Pacific Research Institute
Santa Rosa, California, United States
MedVadis Research
Waltham, Massachusetts, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Center of Clinical Research
Winston-Salem, North Carolina, United States
Pain Specialists of America - South Austin - James Casey
Austin, Texas, United States
Pain Specialists of America - Cedar Park
Cedar Park, Texas, United States
Institute of Precision Pain Medicine
Corpus Christi, Texas, United States
Pain Specialists of America - Round Rock
Round Rock, Texas, United States
Pain Specialists of America - San Marcos
San Marcos, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Related Links
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Sponsor's Website
Other Identifiers
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0156-CSP-000
Identifier Type: -
Identifier Source: org_study_id