Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05769348

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

Led by University of Michigan · Updated on 2026-02-25

80

Participants Needed

1

Research Sites

204 weeks

Total Duration

On this page

Sponsors

U

University of Michigan

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial 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. Another 20 Episodic Migraine patients will be recruited for the observational aim of the study which does not include brain stimulation.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 18 to 65 (inclusive)
  • Patients must have episodic migraines that started before age 50
  • Chronic migraine with headache on 15 or more days per month for more than six months
  • At least eight days per month with migraine features
  • Episodic migraine with headaches less than 8 days per month
  • Willing to limit new treatments and medications during the study period
Not Eligible

You will not qualify if you...

  • Significantly greater pain in body sites other than the head
  • Active, untreated major systemic illness other than migraine
  • Medical conditions impairing health independent of migraine (including cardiopulmonary disorders, malignancy, uncontrolled endocrine or allergies)
  • Systemic rheumatic disorders (rheumatoid arthritis, lupus, gout, fibromyalgia)
  • History or current psychotic disorder or severe major depression (Beck Depression score >30)
  • History of neurological disorders (epilepsy, stroke, neuropathy, neuropathic pain)
  • Medication overuse headache defined by specific medication intake thresholds
  • Current or recent use of opioids or dopaminergic drugs or substance abuse
  • Positive drug test for opioids or recreational drugs at PET visits
  • Allergic reaction to study radiotracers or related drugs
  • Exclusion by MRI or PET safety screening
  • Pregnant or lactating women (negative pregnancy test required before PET)
  • Prior use of transcranial direct current stimulation (tDCS)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

J

Jacqueline Dobson, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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