Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
NCT ID: NCT05769348
Last Updated: 2025-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
80 participants
INTERVENTIONAL
2023-01-26
2025-12-30
Brief Summary
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Detailed Description
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This is a phase 2, single center, three-arm, double-masked, randomized investigation and modulation of the µ-opioid and D2/D3 mechanisms in chronic migraine (in vivo). We will enroll 60 patients with Chronic Migraine divided into 3 Lab/Home-Based groups: 20 for the active unilateral M11-2 HD-tDCS group, 20 for the active bilateral M11-2 HD-tDCS group, and 20 for the sham M11-2 HD-tDCS group. Patients will complete a screening visit, baseline visit with MRI and PET session, 20 days of HD-tDCS brain stimulation treatments, as well as follow-up visits with an MRI and PET session.
Observational Study Arm:
20 additional patients with low frequency EM (\<8 attacks/month) patients (that did not undergo neuromodulation) will be recruited for the study. Historical data may be used in place of recruiting new participants. Data from these 20 EM volunteers will be compared to that of CM patients at baseline; however, they will not be part of the clinical trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active Unilateral Treatment
Chronic migraine patients will be randomized (Taves method) to receive UNILATERAL high-definition transcranial direct current stimulation (HD-tDCS\*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks).
HD-tDCS Active Protocol
non-invasive brain stimulation (active protocol)
Active Bilateral Treatment
Chronic migraine patients will be randomized (Taves method) to receive BILATERAL high-definition transcranial direct current stimulation (HD-tDCS\*) as 20 minute sessions, once daily for 20 days (M-F for 4 weeks).
HD-tDCS Active Protocol
non-invasive brain stimulation (active protocol)
Sham Treatment
Chronic migraine patients will be randomized (Taves method) to receive SHAM high-definition transcranial direct current stimulation (HD-tDCS\*) as 30-second administrations at the beginning and end of each 20 minute session, once daily for 20 days (M-F for 4 weeks).
HD-tDCS Sham Protocol
non-invasive brain stimulation (sham protocol)
No Treatment
Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only).
No interventions assigned to this group
Interventions
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HD-tDCS Active Protocol
non-invasive brain stimulation (active protocol)
HD-tDCS Sham Protocol
non-invasive brain stimulation (sham protocol)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Michigan
OTHER
Responsible Party
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Alexandre DaSilva, DDS, DMedSc
Director of the Headache and Orafacial Pain Effort Lab
Principal Investigators
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Alexandre DaSilva, DDS, DMedSc
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00213295
Identifier Type: -
Identifier Source: org_study_id
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