Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Brigham and Women's Hospital
With
National Center for Complementary and Integrative Health (NCCIH)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Women and men aged ≥18 years
Self-reported clinician diagnosis of migraine with or without aura which does not meet criteria for chronic migraine (according to the International Classification of Headache Disorders 3rd edition)
* Individuals with self-reported migraine will need to report a clinician diagnosis of migraine and be classified as having migraine or probable migraine by the American Migraine Study (AMS) migraine screener. The AMS migraine screener, which has a sensitivity of 100% and a specificity of 82% for the diagnosis of migraine will be used to confirm self-reported migraine status.
* History of migraine dating for at least one year
Self-report of 4 to 20 migraine attacks during the 30 days prior to enrollment in the study
Completion of at least 22 headache diary days during the 28 day run-in period
o Report migraine frequency between 4 to 14 days during the 28 day run-in period
If currently using medications to prevent or treat migraine, no new medication use within the past 3 months
No new use of behavioral interventions within the past 3 months and/or agree to not begin new behavioral interventions during this trial
Be willing to complete all study procedures and be randomized to all interventional groups
Be fluent in English
Own an iPhone or Android device and be willing to download MyCap to the device
You may not be if
Self-reported history of stroke or transient ischemic attack; history of brain surgery or spine surgery; currently receiving treatment for a concussion; and self-reported diagnosis of cluster headache, brain tumor, brain aneurysm, traumatic brain injury, multiple sclerosis, epilepsy, schizophrenia, or bipolar disorder
Kidney failure or current dialysis treatment or any medical condition which the participant believes could lead to difficulty complying with the protocol
Current alcohol or substance abuse (self-reported)
Self-reported clinician diagnosis of medication overuse headache
Currently or recently (past 6 months) received Botox treatment for migraine
Failure to return the baseline urine sample
Currently pregnant, nursing, or intending to become pregnant during the study period.
Unwilling to forgo use of out-of-study supplements of cocoa extract during the trial