RecruitingNot ApplicableNCT05769348

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

Sponsor

University of Michigan

Enrollment

80 participants

Start Date

Jan 26, 2023

Study Type

INTERVENTIONAL

Conditions

Chronic Migraine

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria5

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 Criteria13

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