Effectiveness of Direct Current Stimulation to the head combined with Vagus Nerve Stimulation in the ear for the treatment of women with menstrual migraine

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2026
INTERVENTION: This is a randomized, open‐label, controlled clinical trial composed of two groups of women, sham and intervention. An estimated 52 participants are expected, with the study comprising an intervention group of 26 participants and a sham group also of 26 participants. Five sessions of Transcranial Direct Current Stimulation combined with Transcutaneous Vagus Nerve Stimulation will be performed, one session per week, totaling one month, 5 weeks. Evaluation, intervention, re‐evaluation, and a 180‐day follow‐up will be conducted CONDITION: G43.3 Migraine Disorders ; Complicated migraine PRIMARY OUTCOME: To assess the reduction in frequency and intensity of headaches in the intervention group compared to the sham group, using the Brief Pain Inventory and Pain Diary, considering a 2‐ point reduction in pain as a clinically significant outcome and a 50% reduction in frequency as a clinically significant outcome SECONDARY OUTCOME: No secondary outcomes are expected INCLUSION CRITERIA: Cisgender women; aged 18 to 65 years; diagnosed with Menstrual Migraine according to the 2018 criteria of The International Classification of Headache Disorders (ICHD‐3) for more than 3 months; attacks in menstruating women meeting ICHD‐3 criterion B; attacks (without treatment or with ineffective treatment) occurring exclusively on day 1 ± 2 (i.e., days ‐2 to +3) of menstruation, in at least two of three menstrual cycles; and, additionally, at other times during the cycle
Epistemonikos ID: 84ee2c04fb0b612d89b3b6a40c29055db0197763
First added on: Aug 08, 2026