Clinical trial NCT05491915: The MONARCH Case Series Study: SPRINT® Peripheral Nerve Stimulation for the Treatment of Head 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervicogenic Headache
Occipital Neuralgia
Keywords: Electrical Stimulation
Neuromodulation
Head pain
Headache
Neck pain
Lead sponsor: SPR Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Reduction in average pain and/or reduction in pain interference.
timeFrame: Up to 8-weeks after Start of Therapy (SOT)
measure: Study-Related Adverse Events (AEs)
timeFrame: During the Lead Placement procedure (SOT)
measure: Study-Related Adverse Events (AEs)
timeFrame: 24-48 hours post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 1-week post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 2-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 3-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 4-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 5-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 6-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 7-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 8-weeks post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 3-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 6-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 9-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 12-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 18-months post-SOT
measure: Study-Related Adverse Events (AEs)
timeFrame: 24-months post-SOT
Secondary outcomes:
measure: Reduction in average pain intensity
timeFrame: Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT
measure: Reduction in pain interference
timeFrame: Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT
measure: Reduction in pain medication usage
timeFrame: Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT
Other outcomes:
Locations:
city: Santa Rosa
country: United States
facility: Pacific Research Institute
state: California
city: Waltham
country: United States
facility: MedVadis Research
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Winston-Salem
country: United States
facility: Center of Clinical Research
state: North Carolina
city: Austin
country: United States
facility: Pain Specialists of America - South Austin - James Casey
state: Texas
city: Cedar Park
country: United States
facility: Pain Specialists of America - Cedar Park
state: Texas
city: Corpus Christi
country: United States
facility: Institute of Precision Pain Medicine
state: Texas
city: Round Rock
country: United States
facility: Pain Specialists of America - Round Rock
state: Texas
city: San Marcos
country: United States
facility: Pain Specialists of America - San Marcos
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References: