G43.0
Conditions
Interventions
Group 1: Multifocal stimulation using repetitive peripheral/transcranial magnetic stimulation
The multifocal stimulation protocol includes three components:
-Shoulder and Neck Muscles: The coil is m
Sponsors
Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Kopfschmerzzentrum
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Diagnosis of menstrual migraine according to the International Classification of Headache Disorders (ICHD-3): Attacks occur on day 1 ± 2 of menstruation (i.e., day -2 to +3) in at least 2 out of 3 menstrual cycles, but also at other times during the cycle - more than 3 headache days per month - Regular menstrual cycle (between 21 and 35 days) - If currently undergoing pharmacological migraine prophylaxis: no dosage changes within the last 3 months - Valid health insurance coverage
Exclusion criteria
Exclusion criteria: - Relevant psychiatric disorders (e.g., bipolar disorder, schizophrenia, severe depressive episode) - Epilepsy or use of antiepileptic medication due to a seizure in the last 6 months - Lack of capacity to consent - Pregnancy - Alcohol or drug abuse (regular consumption of more than two alcoholic drinks per day or use of illegal drugs) - History of severe traumatic brain injury - Existing hearing disorders or tinnitus - Metallic foreign bodies in the brain or skull area - Cochlear implants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the number of (perimenstrual) migraine days | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical outcomes: -Change in the number of days with moderate/severe headaches compared to baseline -Change in migraine attack frequency from baseline. - Change in days with need for acute medication - Impact on daily life (measured with the Headache Impact Test-6 (HIT-6)) - Impairment of quality of life (measured with the Migraine Disability Assessment (MIDAS)). Neurophysiologcial outcomes: -Effects on the autonomic nervous system, assessed via cortisol response and heart rate variability (HRV). -Effects on the trigemino-vascular system, measured by concentrations of calcitonin gene-related peptide (CGRP). -Neuroinflammatory effects, determined by levels of interleukin (IL) 1ß, 6, and 10. -Effects on cortical excitability, evaluated through measurements of motor evoked potentials (MEPs) -Effects on central habituation, assessed by the R2 component of the nociceptive blink reflex (nBR). | — |
Countries
Germany
Contacts
Public ContactCornelius Angerhöfer
Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Kopfschmerzzentrum
Outcome results
None listed