Migraine, headache disorders, primary headache disorders Migraine, severe headache
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Signed written informed consent.Participant is currently responding to MySalvia therapy in the RELIEF study (defined as =30% reduction in monthly migraine days compared to baseline).Willing and able to comply with study requirements, including travel to Rotterdam
Exclusion criteria
Exclusion criteria: Skin conditions on the forehead that may interfere with measurementsSerious medical or psychiatric conditions that may compromise participation (e.g., HIV, hepatitis B/C, cancer, psychiatric disorders according to DSM-5 such as depression, schizophrenia, suicidality).History of allergy or sensitivity to capsicum fruits (e.g., chili peppers).Other: insufficient mastery of Dutch or English; current substance dependence (alcohol, illicit drugs, tranquilizers, narcotics, analgesics).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total number of artefacts during LSCI measurements aggregated for Day 1 and Day 2, stratified by baseline and active stimulation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Optimal reservoir placement (based on artefact frequency) and dermal blood flow parameters in response to capsaicin with and without stimulation, including maximal response (?Emax) and area under the curve (AUC0–40). | — |
Countries
Netherlands
Contacts
Erasmus MC, Universitair Medisch Centrum Rotterdam