Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
Chronic Migraine
About this trial
This is an interventional treatment trial for Chronic Migraine
Eligibility Criteria
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
Sites / Locations
- University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Sham Comparator
No Intervention
Active Unilateral Treatment
Active Bilateral Treatment
Sham Treatment
No Treatment
Chronic migraine patients will be randomized (Taves method) to receive UNILATERAL high-definition transcranial direct current stimulation (HD-tDCS*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks).
Chronic migraine patients will be randomized (Taves method) to receive BILATERAL high-definition transcranial direct current stimulation (HD-tDCS*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks).
Chronic migraine patients will be randomized (Taves method) to receive SHAM high-definition transcranial direct current stimulation (HD-tDCS*) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 20 days (M-F for 4 weeks).
Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only).