💬In plain words
What the trial is, and whether it could suit you
This study investigates whether unilateral and bilateral non-invasive brain stimulation, given for 20 minutes/once per day for twenty days (M-F) can reduce migraine pain. Fourty patients will receive treatment (20 unilateral treatment, and 20 bilateral treatment), while twenty will receive a "sham" procedure. Another 20 Episodic Migraine patients will be recruited for the observational aim of the study which does not include brain stimulation.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Male or female, aged 18 to 65 (inclusive)
* Patients must have Episodic migraines that started before the age of 50, and currently experience:
* Chronic migraine (ICHD-3-beta), headache occurring on 15 days/month for more than six months, which, on at least eight days/month, has the features of a migraine headache.
* Episodic migraine (low frequency), specifically those with headache occurring less than 8 days/month.
* Willing to limit the introduction of new treatments and medications during the study period.
Exclusion Criteria:
* Significantly greater pain in body sites other than the head
* Active, untreated major concurrent systemic illness other than migraine
* Medical conditions that can impair health status independent of migraine (including cardiopulmonary disorders, malignancy, uncontrolled endocrine or allergies)
* Systemic rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia);
* History or current evidence of a psychotic disorder (e.g., bipolar disorder, schizophrenia) or severe major depression, as evidenced by Beck Depression score of \>30\*
* History of neurological disorder (e.g., epilepsy, stroke, neuropathy, neuropathic pain)
* Medication overuse headache (ICHD-3), regular intake for ≥10 days per month of ergotamine, triptans, combination analgesics, or any combination thereof OR ≥15 days per month of simple analgesics (acetaminophen, aspirin, NSAID), for more than 3 months
* Current use of opioid or dopaminergic drugs (or use within the last 3 months) or substance abuse (self-reported)
* Drug test positive for opioid or recreational drug (e.g., cannabis) at the time of the PET scan visits
* Allergic response to study radiotracers or chemically related drugs
* Excluded by MRI Center or PET Center safety screening checklist (as administered by study staff)
* Pregnant or lactating (negative urine pregnancy test must be available before any PET procedures are initiated)
* Prior use of tDCS
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