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

Study Overview
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Brief Summary
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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
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The MONARCH (Multicenter Occipital Neuralgia and Cervicogenic Headache) Case Series Study: Treatment of Head Pain With the SPRINT® Peripheral Nerve Stimulation (PNS) System

Conditions
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Cervicogenic Headache, Occipital Neuralgia

Intervention / Treatment
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* Device: SPRINT Peripheral Nerve Stimulation (PNS) System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral Nerve Stimulation<br>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. | Device: SPRINT Peripheral Nerve Stimulation (PNS) System<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | During the Lead Placement procedure (SOT) | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 24-48 hours post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 1-week post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 2-weeks post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 3-weeks post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 4-weeks post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 5-weeks post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 6-weeks post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 7-weeks post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 8-weeks post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 3-months post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 6-months post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 9-months post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 12-months post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 18-months post-SOT | 
| Study-Related Adverse Events (AEs) | Occurrence and type of study-related AEs | 24-months post-SOT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in average pain intensity | Average pain scores measured using question 5 from the Brief Pain Inventory- Short Form. | Baseline, 8-weeks after SOT | 
| Reduction in pain interference | Average pain interference scores measured using question 9 from the Brief Pain Inventory- Short Form. | Baseline, 8-weeks after SOT | 
| Reduction in pain medication usage | Analgesic medication consumption will be collected. | Baseline, 8-weeks after SOT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electrical Stimulation, Neuromodulation, Head pain, Headache, Neck pain