NCT05769348 · University of Michigan
Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
HD-tDCS Active Protocol
non-invasive brain stimulation (active protocol)
DEVICE
HD-tDCS Sham Protocol
non-invasive brain stimulation (sham protocol)
Primary outcome measures
Change from baseline in moderate to severe headache days over 1 month follow-up
Time frame: baseline to 1 month follow-up
Headache Day: day with a headache that causes moderate or severe pain (at its peak, defined as NRS ≥ 4) that lasts at least 4 hours, OR day with a headache that is treated by an acute headache medication.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Ann Arbor, Michigan
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 25, 2026 · Source of record for eligibility and locations