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Investigating Brain Stimulation for Chronic Migraine

This study is looking into whether a type of non-invasive brain stimulation, called HD-tDCS, can help reduce migraine pain for people with chronic migraine. Researchers want to see if applying this stimulation for 20 minutes a day, five days a week for four weeks, makes a difference. You could be eligible if you are between 18 and 65 years old and have chronic migraine, meaning you experience headaches on 15 or more days a month, with at least eight of those being migraine days. The main goal is to see how many days you experience moderate to severe headaches after one month of follow-up. The study aims to enroll 80 participants, but the current recruitment status is unclear.

Study design
This is a Phase 2, single-center, double-masked, randomized study involving 60 participants with chronic migraine, divided into three groups. An additional 20 participants with episodic migraine will be recruited for an observational part of the study.
What's involved
If you participate in the clinical trial, you would have a screening visit, a baseline visit with MRI and PET scans, 20 days of HD-tDCS brain stimulation treatments, and follow-up visits with MRI and PET scans.
Compensation
Not stated in the trial record.
Follow-up
Your headache days will be measured at baseline and again after one month of follow-up.

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NCT05769348

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

Recruiting
NAAges 18–65InterventionalTreatment
University of Michigan
~80 participants
Updated 2026-02-25 on ClinicalTrials.gov
What's tested:HD-tDCS Active ProtocolHD-tDCS Sham Protocol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in moderate to severe headache days over 1 month follow-up
Measured over baseline to 1 month follow-up

Conditions

Chronic Migraine

Explore related trials

Chronic MigraineEpisodic migraine

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Alexandre DaSilva, DDS, DMedSc · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Jacqueline Dobson, BA
[email protected]
(734)763-8469
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from baseline in moderate to severe headache days over 1 month follow-upbaseline to 1 month follow-up

    Headache Day: day with a headache that causes moderate or severe pain (at its peak, defined as NRS ≥ 4) that lasts at least 4 hours, OR day with a headache that is treated by an acute headache medication.