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

Not Applicable

Recruiting

• Conditions: Occipital Neuralgia; Cervicogenic Headache
• Interventions: Device: SPRINT Peripheral Nerve Stimulation (PNS) System

• Registration Number: NCT05491915
• Lead Sponsor: SPR Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-04
• Study First Submitted QC: 2022-08-04
• Study First Posted: 2022-08-08
• Study Start: 2022-10-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral Nerve Stimulation	SPRINT Peripheral Nerve Stimulation (PNS) System	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.

Primary Outcome Measures

Name	Time	Method
Reduction in average pain and/or reduction in pain interference.	Up to 8-weeks after Start of Therapy (SOT)	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.
Study-Related Adverse Events (AEs)	24-months post-SOT	Occurrence and type of study-related AEs

Secondary Outcome Measures

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

Trial Locations

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 - San Marcos; 🇺🇸 San Marcos, Texas, United States

Pain Specialists of America - Round Rock; 🇺🇸 Round Rock, Texas, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States