🏛️ Verified NIH Record • Updated 2026-02-23

Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo) (NCT05769348)

🟢 Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: University of Michigan

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (14 items).

Location: University of Michigan — Ann Arbor, Michigan

Age range: 18 Years to 65 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • 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)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • University of Michigan — Ann Arbor, Michigan

📞 Contact the Study Coordinator

Phone: (734) 763-8469

Email: contactHOPE@umich.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: Fourty patients will receive treatment (20 unilateral treatment, and 20 bilateral treatment), while twenty will receive a "sham" procedure.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗