Non-invasive brain stimulation for chronic migraine relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of unilateral and bilateral non-invasive brain stimulation on chronic migraine patients. A total of 60 participants will be randomly assigned to receive either active brain stimulation or a sham procedure over 20 days, with follow-up assessments including MRI and PET scans. Additionally, 20 patients with episodic migraines will be observed to compare their data with chronic migraine patients. The study aims to explore the modulation of central mu-opioid mechanisms in migraine management.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Alexandre DaSilva, DDS, DMedSc — University of Michigan
• Study coordinator: Jacqueline Dobson, BA
• Email: contactHOPE@umich.edu
• Phone: (734)763-8469

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.