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This study examined the effect of transcranial direct current stimulation (a mild electrical stimulation applied to the brain) added to treatment with monoclonal antibodies acting on the CGRP pathway in migraine patients. It enrolled patients aged 40-70 with migraine, with or without aura, who still had frequent migraine days despite anti-CGRP antibody treatment. This study has no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * male or female patients, aged between 40 and 70 years, referring to the Headache Center of the University of L'Aquila; * a diagnosis of migraine with or without aura according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3; https://ichd-3.org/); * age at onset of migraine \<50 years; * migraine must have been present for at least ≥ 12 months; * treated with CGRP-MAbs (erenumab, fremanezumab or galcanezumab) according to clinical practice criteria for 90-180 days since the first subcutaneous administration (this time range was chosen to ensure a stable CGRP pathway inhibition); * reporting \>4 monthly migraine days in the last 30 days of observation despite treatment with CGRP-MAbs; * able to discriminate between migraine and tension-type headaches; * written informed consent to participate in the study Exclusion Criteria: * any migraine preventive medication other than CGRP-MAbs; * secondary migraine; * epilepsy or any other neurologic condition that may be worsened by transcranial electrical stimulation; * metallic head implants, cardiac pacemaker or any other device that could malfunction or be displaced by electrical stimulation; * pregnancy or lactation.