NCT05769348Recruiting
Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 13 Feb 2023
- Start date
- Jan 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Michigan
- Diseases
- Migraine
- NCT number
- NCT05769348
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Jan 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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);
- 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
- Prior use of tDCS
Other illness
- 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)
- Allergic response to study radiotracers or chemically related drugs
Other
- Significantly greater pain in body sites other than the head
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.