An interventional study of HD-tDCS Active Protocol and HD-tDCS Sham Protocol in Chronic Migraine, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
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.
Clinical Trial:
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.
University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients must have Episodic migraines that started before the age of 50, and currently experience:
Exclusion Criteria:
Active, untreated major concurrent systemic illness other than migraine
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).
Device: HD-tDCS Active Protocol
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).
Device: HD-tDCS Active Protocol
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).
Device: HD-tDCS Sham Protocol
Episodic Migraine Patients will not receive study treatment. These patients will complete observational study components (Screening visit, baseline visit, MRI and PET scan only).
non-invasive brain stimulation (active protocol)
non-invasive brain stimulation (sham protocol)
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.
Time frame: baseline to 1 month follow-up
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.
Time frame: baseline to 1 month follow-up
Responder rate over 1-month follow-up
50% percent reduction (from baseline to post tDCS) in the number of moderate or severe headache days.
Time frame: baseline to 1 month follow-up
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
Time frame: baseline to 1 month follow-up
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.
Time frame: baseline to 1 month follow-up
Plan to share: No
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University of Michigan