Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces the number of migraines preventatively.
Stanford is currently accepting patients for this trial.
Intervention(s):
- device: gammaCore Sapphire active
- device: gammaCore Sapphire Sham
Eligibility
Key Inclusion Criteria:
- Between the ages of 18 and 75 years
- Been previously diagnosed with migraine (with or without aura), in accordance with the
ICHD-3 criteria
- Experiences between 8 to 20 headaches days per month (during the last 3 months), with
at least 5 of them being migraine days
- Onset of migraine at age 50 years or younger
- Agrees to refrain from initiating or changing any prophylactic medications for
indications other than migraine
Key Exclusion Criteria:
- Concomitant medical condition that will require oral or injectable steroids during the
study
- Currently on a stable regime of more than 1 migraine preventative therapy
- Other significant pain problem (e.g., cancer pain, fibromyalgia, other head or facial
pain disorder)
- Known or suspected severe cardiac disease (e.g., symptomatic coronary artery disease,
prior myocardial infarction, congestive heart failure)
- Known or suspected cerebrovascular disease
- Previous cervical vagotomy
- Currently implanted with an electrical and/or neurostimulator device
- Been implanted with metal cervical spine hardware or has a metallic implant near the
nVNS stimulation site
- Known history or suspicion of secondary headache
- Currently using marijuana (including medical marijuana) or has used marijuana
(including medical marijuana) or cannabidiol oil within the last 6 months
- Currently takes simple analgesics or NSAIDs >15 days per month or triptans, ergots, or
combined analgesics >10 days per month for headaches or other body pain
- Currently takes prescription opioids more than 2 days per month for headaches or body
pain
- Failed an adequate trial (2 months or greater) of at least 3 classes of a drug therapy
for migraine prevention
- Surgery for migraine prevention
- Undergone nerve block (occipital or other) in the head or neck within the last 3
months
- Received Botox or CGRP mAb injections within the last 6 months
- Pregnant or thinking of becoming pregnant during the study period, or of childbearing
years and unwilling to use an accepted form of birth control
- Previously used gammaCore
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Stephanie Tran
I'm interested
Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation, mobile application development, and pharmaceutical trials.
Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.