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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients will complete a screening visit, baseline visit with MRI and PET session, 20 days of HD-tDCS brain stimulation treatments, as well as follow-up visits with an MRI and PET session."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether brain stimulation without surgery can reduce migraine pain in adults ages 18 to 65. Stimulation is given on one or both sides for 20 minutes a day, Monday through Friday, for 20 treatment days; some people get a sham (pretend) treatment. A separate group with occasional migraines is observed without brain stimulation.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old.
  • Have migraines that started before age 50.
  • Have either headaches on 15 or more days a month for over 6 months, with migraine symptoms on at least 8 days a month, OR headaches on fewer than 8 days a month.
  • Be willing to limit starting new treatments and medicines during the study.

Who can't join

  • Have much worse pain somewhere other than your head.
  • Have a serious, active, untreated illness besides migraine that affects your health, such as heart or lung disease, cancer, uncontrolled hormone problems or allergies; or have rheumatoid arthritis, lupus, gout, or fibromyalgia.
  • Have a past or current mental illness such as bipolar disorder or schizophrenia, severe depression with a Beck Depression score above 30, or a brain or nerve disorder such as seizures, stroke, nerve damage, or nerve pain.
  • Have headaches from overusing pain medicine for more than 3 months: ergotamine, triptans, or combined pain medicines on at least 10 days a month, or acetaminophen, aspirin, or NSAIDs on at least 15 days a month.
  • Use opioid medicines or drugs that affect dopamine (a brain chemical), or used them in the past 3 months; report drug abuse; or test positive for opioids or recreational drugs, such as cannabis, at PET scan visits.
  • Are allergic to the study's radioactive scan tracers or related drugs, or do not pass MRI or PET scan safety checks.
  • Are pregnant or breastfeeding. A negative urine pregnancy test is required before any PET scan procedure.
  • Have previously used tDCS, a type of brain stimulation using a weak electrical current.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

MI