Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
University of Michigan
Summary
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.
Description
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.…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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/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: * Significantly greater pain in bo…
Interventions
- DeviceHD-tDCS Active Protocol
non-invasive brain stimulation (active protocol)
- DeviceHD-tDCS Sham Protocol
non-invasive brain stimulation (sham protocol)
Location
- University of MichiganAnn Arbor, Michigan