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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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

Primary outcome measure(s)

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

Trial sites (10)