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

Cervicogenic Headache Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491915
• Other study ID #: 0156-CSP-000
• Status: Recruiting
• Phase: N/A
• Start date: October 24, 2022
• Est. completion date: August 2026

Study information

• Verified date: April 2024
• Source: SPR Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). This device is cleared by the FDA for up to 60 days of use for relief of chronic or acute pain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Neuralgia
• Occipital Neuralgia
• Post-Traumatic Headache

Intervention

Device:
• 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

Country	Name	City	State
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	Mayo Clinic Rochester	Rochester	Minnesota
United States	Pain Specialists of America - Round Rock	Round Rock	Texas
United States	University of Utah	Salt Lake City	Utah
United States	Pain Specialists of America - San Marcos	San Marcos	Texas
United States	Pacific Research Institute	Santa Rosa	California
United States	MedVadis Research	Waltham	Massachusetts
United States	Center of Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
SPR Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 8-weeks after Start of Therapy (SOT)
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	During the Lead Placement procedure (SOT)
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	24-48 hours post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	1-week post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	2-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	3-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	4-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	5-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	6-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	7-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	8-weeks post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	3-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	6-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	9-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	12-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	18-months post-SOT
Primary	Study-Related Adverse Events (AEs)	Occurrence and type of study-related AEs	24-months post-SOT
Secondary	Reduction in average pain intensity	Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form.	Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT
Secondary	Reduction in pain interference	Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form.	Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT
Secondary	Reduction in pain medication usage	Analgesic medication consumption will be collected.	Baseline, 8-weeks after SOT, 3-months after SOT, 6-months after SOT, 9-months after SOT, 12-months after SOT

External Links

•   Sponsor's Website