Investigation and Modulation of the Central Mu-Opioid Mechanism in Migraine (in Vivo)
ConditionChronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
Qualifiers
Male or female, aged 18 to 65 (inclusive)
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.
Disqualifiers
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);
Trial design
Treatments tested in this trial
- HD-tDCS Active Protocol
- HD-tDCS Sham Protocol
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Michigan
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov