SPRINT Peripheral Nerve Stimulation (PNS) System for Cervicogenic Headaches

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Center of Clinical Research, Winston-Salem, NC
Cervicogenic Headaches+4 More
SPRINT Peripheral Nerve Stimulation (PNS) System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Cervicogenic Headaches
  • Occipital Neuralgia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: 24-months post-SOT

24-months post-SOT
Study-Related Adverse Events (AEs)
Baseline, 8-weeks after SOT
Reduction in average pain intensity
Reduction in pain interference
Reduction in pain medication usage
Up to 8-weeks after Start of Therapy (SOT)
Reduction in average pain and/or reduction in pain interference.

Trial Safety

Trial Design

1 Treatment Group

Peripheral Nerve Stimulation
1 of 1
Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: SPRINT Peripheral Nerve Stimulation (PNS) System · No Placebo Group · N/A

Peripheral Nerve Stimulation
Device
Experimental Group · 1 Intervention: SPRINT Peripheral Nerve Stimulation (PNS) System · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SPRINT Peripheral Nerve Stimulation (PNS) System
2017
N/A
~220

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24-months post-sot
Closest Location: Center of Clinical Research · Winston-Salem, NC
N/AFirst Recorded Clinical Trial
1 TrialsResearching Cervicogenic Headaches
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a diagnosis of cervicogenic headache (CGH) or occipital neuralgia (ON).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.