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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Chronic Migraine

In brief

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.

Key facts

Study ID: NCT05769348
Run by: University of Michigan
People needed: 80
Starts: 2023-01-26
Expected to finish: 2026-12-30
Last updated by the study team: 2026-02-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

University of Michigan — Ann Arbor, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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