About this trial
The purpose of this study is to prospectively investigate the temporal sequence of premonitory symptoms across multiple migraine attacks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of episodic (EM) or chronic migraine (CM) or CM with medication overuse headache (MOH) according to ICHD-III criteria;
Age between 18 and 65 years;
At least 2 migraine days (MMD) in the month preceding the inclusion;
Migraine history of at least 12 months prior to inclusion
Disqualifiers
History or current diagnosis of secondary headache disorders as defined by ICHD-III;
History of other neurological comorbidities or major psychiatric disorders;
History of migraine for < 12 months prior to the inclusion;
Opioid overuse according to the ICHD-III criteria;
Trial population
Prospective, longitudinal, multicentric study on patients with migraine attending the outpatient clinic of Italian Headache centres who will meet the inclusion and exclusion criteria.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Frequency of each symptom as the first premonitory symptom
Premonitory symptoms will be recorded at the beginning of each migraine attack for a maximum of 5 migraine attacks per participant. For each premonitory symptom, the percentage of recorded attacks in which it was reported as the first symptom of the premonitory phase. Symptoms are recorded at headache onset for each attack via a structured electronic diary, capturing the type, sequence, onset, and duration of symptoms preceding the pain phase. The denominator is the number of recorded attacks with a premonitory phase.
Secondary outcomes
Time from onset of each premonitory symptom to headache onset (categorical intervals)
Premonitory symptoms will be recorded at the beginning of each migraine attack for a maximum of 5 migraine attacks per participant. For each premonitory symptom, the time of onset relative to headache onset, classified into predefined intervals: simultaneous with pain onset; less than 1 hour before; 1 to 2 hours before; more than 2 to 6 hours before; more than 6 to 12 hours before. Results are reported as the distribution of attacks across intervals for each symptom (percentage of recorded attacks). Onset times are recorded at headache onset for each attack via a structured electronic diary.
Time from onset of each premonitory symptom to headache onset (minutes)
Premonitory symptoms will be recorded at the beginning of each migraine attack for a maximum of 5 migraine attacks per participant. For each premonitory symptom, the time interval in minutes between its onset and headache onset, recorded for each attack via a structured electronic diary. Results are summarised per symptom (e.g., median minutes before headache onset).
Intra-subject consistency of premonitory symptoms across attacks
Premonitory symptoms will be recorded at the beginning of each migraine attack for a maximum of 5 migraine attacks per participant. The degree of within-subject agreement in the presence and chronology of premonitory symptoms across multiple attacks of the same participant, recorded via a structured electronic diary. Agreement is summarised per participant and reported across the sample (e.g., concordance in symptom presence and chronology).
Evolution and persistence of premonitory symptoms during the headache phase
Premonitory symptoms will be recorded at the beginning of each migraine attack for a maximum of 5 migraine attacks per participant. For each premonitory symptom, the evolution and persistence after headache onset, recorded via a structured electronic diary.
Other outcomes
Patterns of premonitory symptom transition and clustering
Premonitory symptoms will be recorded at the beginning of each migraine attack for a maximum of 5 migraine attacks per participant. Identification of recurrent patterns in the transition between premonitory symptoms and in their co-occurrence (clustering), across all recorded attacks. Symptom sequences are recorded via a structured electronic diary and analysed using sequence analysis and probabilistic modelling approaches (e.g., transition probabilities between symptoms and identification of symptom clusters).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Roma La Sapienza
Lead sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborator
University of Modena and Reggio Emilia
Collaborator
University of Bari
Collaborator
Campus Bio-Medico University
Collaborator
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Collaborator
Azienda USL Ferrara
Collaborator
University of Florence
Collaborator
Azienda Ospedaliero-Universitaria Careggi
Collaborator
Azienda Ospedaliero Universitaria Policlinico Modena
Collaborator
Ospedale di Piove di Sacco
Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Collaborator
Cliniche Humanitas Gavazzeni
Collaborator
Carlo Besta Neurological Institute
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator