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Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)

Recruiting

Who can join

Ages 18 to 65 · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: University of Michigan · Participants: 80 · Started: Jan 26, 2023

Contact the study team

Official record on ClinicalTrials.gov — NCT05769348

Locations in the U.S.

MichiganUniversity of Michigan, Ann Arbor

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.