[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05769348":3,"trial-entities:NCT05769348":112,"trial-summary:NCT05769348":116},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":40,"secondary_outcomes":45,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":14,"eligibility_criteria":61,"std_ages":83,"locations":86,"central_contacts":101,"overall_officials":106,"references":110,"see_also_links":111},"NCT05769348","HUM00213295","Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)","RECRUITING","2026-12-30","2026-02","2026-02-25","2023-01-26","University of Michigan","OTHER",false,"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.","Clinical Trial:\n\nThis is a phase 2, single center, three-arm, double-masked, randomized investigation and modulation of the µ-opioid and D2\u002FD3 mechanisms in chronic migraine (in vivo). We will enroll 60 patients with Chronic Migraine divided into 3 Lab\u002FHome-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.\n\nObservational Study Arm:\n\n20 additional patients with low frequency EM (\\\u003C8 attacks\u002Fmonth) 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.",[18],"Chronic Migraine",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},80,"ESTIMATED",[28,35],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","HD-tDCS Active Protocol","non-invasive brain stimulation (active protocol)",[33,34],"Active Bilateral Treatment","Active Unilateral Treatment",{"type":29,"name":36,"description":37,"armGroupLabels":38},"HD-tDCS Sham Protocol","non-invasive brain stimulation (sham protocol)",[39],"Sham Treatment",[41],{"measure":42,"description":43,"timeFrame":44},"Change from baseline in moderate to severe headache days over 1 month follow-up","Headache Day: day with a headache that causes moderate or severe pain (at its peak, defined as NRS ≥ 4) that lasts at least 4 hours, OR day with a headache that is treated by an acute headache medication.","baseline to 1 month follow-up",[46,49,52,55],{"measure":47,"description":48,"timeFrame":44},"Change from baseline in headache days over 1-month follow-up","Day with a headache that lasts at least 2 hours, OR day with a headache that is treated by an acute headache medication.",{"measure":50,"description":51,"timeFrame":44},"Responder rate over 1-month follow-up","50% percent reduction (from baseline to post tDCS) in the number of moderate or severe headache days.",{"measure":53,"description":54,"timeFrame":44},"Changes from baseline in medication use days over 1-month follow-up","\\- Medication use is defined as a day when the patient reports intake of medication for the acute treatment of headache",{"measure":56,"description":57,"timeFrame":44},"Intensity of headache over 1-month follow-up","Each headache day is rated in terms of maximum intensity on a 0 to 10 NRS scale and averaged headache intensity will be used.","ALL","18 Years","65 Years",{"inclusion":62,"exclusion":68,"raw_text":82},[63,64,65,66,67],"Male or female, aged 18 to 65 (inclusive)","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\u002Fmonth for more than six months, which, on at least eight days\u002Fmonth, has the features of a migraine headache.","Episodic migraine (low frequency), specifically those with headache occurring less than 8 days\u002Fmonth.","Willing to limit the introduction of new treatments and medications during the study period.",[69,70,71,72,73,74,75,76,77,78,79,80,81],"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)","Pregnant or lactating (negative urine pregnancy test must be available before any PET procedures are initiated)","Prior use of tDCS","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",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":12,"status":7,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":98},"Ann Arbor","Michigan","48109","United States",[93],{"name":94,"role":95,"phone":96,"email":97},"Jacqueline Dobson","CONTACT","734-763-8469","ContactHOPE@umich.edu",{"lat":99,"lon":100},42.27756,-83.74088,[102],{"name":103,"role":95,"phone":104,"email":105},"Jacqueline Dobson, BA","(734)763-8469","contactHOPE@umich.edu",[107],{"name":108,"affiliation":12,"role":109},"Alexandre DaSilva, DDS, DMedSc","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[18,114],"Episodic migraine",[],{"nct_id":4,"found":117,"summary":118,"prompt_version":128},true,{"design":119,"status":120,"heading":121,"summary":122,"follow_up":123,"word_count":124,"commitments":125,"compensation":126,"drugs_mentioned":127},"This is a Phase 2, single-center, double-masked, randomized study involving 60 participants with chronic migraine, divided into three groups. An additional 20 participants with episodic migraine will be recruited for an observational part of the study.","completed","Investigating Brain Stimulation for Chronic Migraine","This study is looking into whether a type of non-invasive brain stimulation, called HD-tDCS, can help reduce migraine pain for people with chronic migraine. Researchers want to see if applying this stimulation for 20 minutes a day, five days a week for four weeks, makes a difference. You could be eligible if you are between 18 and 65 years old and have chronic migraine, meaning you experience headaches on 15 or more days a month, with at least eight of those being migraine days. The main goal is to see how many days you experience moderate to severe headaches after one month of follow-up. The study aims to enroll 80 participants, but the current recruitment status is unclear.","Your headache days will be measured at baseline and again after one month of follow-up.",118,"If you participate in the clinical trial, you would have a screening visit, a baseline visit with MRI and PET scans, 20 days of HD-tDCS brain stimulation treatments, and follow-up visits with MRI and PET scans.","Not stated in the trial record.",[],"v2"]