NCT05769348 Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
| NCT ID | NCT05769348 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Chronic Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-01-26 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-01-26 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Alexandre DaSilva, DDS, DMedSc
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT05769348 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05769348 currently recruiting?
Yes, NCT05769348 is actively recruiting participants. Contact the research team at contactHOPE@umich.edu for enrollment information.
Where is the NCT05769348 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT05769348 clinical trial?
NCT05769348 is sponsored by University of Michigan. The principal investigator is Alexandre DaSilva, DDS, DMedSc at University of Michigan. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.