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The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head Pain
Sponsor: SPR Therapeutics, Inc.
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2022-10-24
Completion Date
2027-08
Last Updated
2025-12-17
Healthy Volunteers
No
Conditions
Interventions
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).
Locations (10)
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