Chronology and Sequence of Premonitory Symptoms

ConditionMigraine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversity of Roma La Sapienza

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 1 trial group
Group A: patients with migraine

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 6 months

Secondary outcomes

1

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 frame
up to 6 months
2

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).

Time frame
Up to 6 months
3

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).

Time frame
Up to 6 months
4

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.

Time frame
Up to 6 months

Other outcomes

1

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).

Time frame
Up to 6 months

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