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

Launched by UNIVERSITY OF MICHIGAN · Mar 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to help people with chronic migraines manage their pain. The study will test two types of non-invasive brain stimulation: one that targets one side of the brain (unilateral) and one that targets both sides (bilateral). Participants will receive this treatment for 20 minutes each day, five days a week, for four weeks. The goal is to see if this stimulation can reduce migraine pain compared to a "sham" procedure (a fake treatment). Additionally, another group of patients with episodic migraines (those who experience fewer headaches) will be observed but will not receive any brain stimulation.

To participate, individuals must be between 18 and 65 years old and have chronic migraines, meaning they have headaches 15 or more days a month for at least six months. They should also be willing to limit new treatments during the study. The trial is currently recruiting participants, including both men and women. If you join, you can expect to receive either the active treatment or the sham procedure while being monitored for changes in your migraine pain. It's important to note that participants with certain health conditions, mental health disorders, or those currently using specific medications may not be eligible for the trial.

Gender

ALL

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