Actively Recruiting
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
Eligibility Criteria
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
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
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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