[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498368":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":68,"collaborators":70,"id":74,"slug":28,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":28,"eligibilityCriteria":78,"healthyVolunteers":75,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":28,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":28,"overallStatus":51,"whyStopped":28,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14,18,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Unilateral Treatment","ACTIVE_COMPARATOR","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).",[13],"Device: HD-tDCS Active Protocol",{"label":15,"type":10,"description":16,"interventionNames":17},"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).",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Sham Treatment","SHAM_COMPARATOR","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).",[23],"Device: HD-tDCS Sham Protocol",{"label":25,"type":26,"description":27,"interventionNames":28},"No Treatment","NO_INTERVENTION","Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only).",null,[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":28},"DEVICE","HD-tDCS Active Protocol","non-invasive brain stimulation (active protocol)",[15,9],{"type":31,"name":36,"description":37,"armGroupLabels":38,"otherNames":28},"HD-tDCS Sham Protocol","non-invasive brain stimulation (sham protocol)",[19],[40],{"name":41,"affiliation":5,"role":42},"Alexandre DaSilva, DDS, DMedSc","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":28,"email":48},"Jacqueline Dobson, BA","CONTACT","(734)763-8469","contactHOPE@umich.edu",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-83.74088,42.27756,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":66,"phoneExt":28,"email":67},"Jacqueline Dobson","734-763-8469","ContactHOPE@umich.edu",{"type":42,"investigatorFullName":41,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"Director of the Headache and Orafacial Pain Effort Lab",[71],{"name":72,"class":73},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH","100498368",false,"NCT05769348","Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)","Inclusion Criteria:\n\n* Male or female, aged 18 to 65 (inclusive)\n* Patients must have Episodic migraines that started before the age of 50, and currently experience:\n\n  * Chronic migraine (ICHD-3-beta), headache occurring on 15 days\u002Fmonth for more than six months, which, on at least eight days\u002Fmonth, has the features of a migraine headache.\n  * Episodic migraine (low frequency), specifically those with headache occurring less than 8 days\u002Fmonth.\n* Willing to limit the introduction of new treatments and medications during the study period.\n\nExclusion Criteria:\n\n* Significantly greater pain in body sites other than the head\n* Active, untreated major concurrent systemic illness other than migraine\n\n  * Medical conditions that can impair health status independent of migraine (including cardiopulmonary disorders, malignancy, uncontrolled endocrine or allergies)\n  * Systemic rheumatic disorders (i.e., rheumatoid arthritis, systemic lupus erythematosus, gout, and fibromyalgia);\n* 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\\*\n* History of neurological disorder (e.g., epilepsy, stroke, neuropathy, neuropathic pain)\n* 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\n* Current use of opioid or dopaminergic drugs (or use within the last 3 months) or substance abuse (self-reported)\n* Drug test positive for opioid or recreational drug (e.g., cannabis) at the time of the PET scan visits\n* Allergic response to study radiotracers or chemically related drugs\n* Excluded by MRI Center or PET Center safety screening checklist (as administered by study staff)\n* Pregnant or lactating (negative urine pregnancy test must be available before any PET procedures are initiated)\n* Prior use of tDCS","ALL","18 Years","65 Years",{"count":83,"type":84},80,"ESTIMATED","INTERVENTIONAL",[87],"NA","This study investigates whether unilateral and bilateral non-invasive brain stimulation, given for 20 minutes\u002Fonce 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.",[90],"Chronic Migraine","2026-02-23",{"date":93,"type":94},"2026-02-25","ACTUAL",{"date":96,"type":94},"2023-01-26",{"date":98,"type":84},"2026-12-30",{"name":5,"class":6},1]