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Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
Recruiting
I'm InterestedTrial ID: NCT03716505
Purpose
The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces
the number of migraines preventatively.
Official Title
A Randomized, Multicenter, Double-blind, Parallel, Sham-controlled Study of Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines. (Premium II)
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
Intervention(s):
device: gammaCore Sapphire active
device: gammaCore Sapphire Sham
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Stephanie Tran