ITACA is a prospective, multicenter, observational longitudinal cohort study conducted in routine clinical practice at six Italian headache centers. Approximately 800 adults with trigeminal autonomic cephalalgias (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) diagnosed according to ICHD-3 will be enrolled. The study will describe clinical features and real-world treatment patterns and will evaluate treatment effectiveness and tolerability, changes in clinical features over time, comorbidities, lifestyle factors, patient-reported outcomes, and predictors of treatment response and disease progression. No investigational intervention will be assigned; treatments are prescribed by treating physicians as part of routine clinical care. Participants will be assessed at baseline and during routine follow-up visits, approximately every 3-6 months or as clinically indicated, for up to 3 years. Relevant clinical data already available in medical records before enrollment may also be collected to improve baseline characterization and reconstruction of disease course.
Age 18 years or older.
Diagnosis of trigeminal autonomic cephalalgia (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) according to ICHD-3 criteria.
Ability to provide written informed consent.
Availability for longitudinal follow-up and data collection.
Secondary headache disorders.
Uncertain or unconfirmed diagnosis of a trigeminal autonomic cephalalgia.
Severe cognitive impairment or psychiatric condition interfering with reliable data collection.
Any condition that, in the investigator's judgment, may compromise participation or follow-up.
Adult outpatients with an ICHD-3 diagnosis of trigeminal autonomic cephalalgia (cluster headache, paroxysmal hemicrania, SUNCT, SUNA, or hemicrania continua) evaluated at specialized headache centers participating in the study.
Cohort
Prospective
Not listed
Baseline and routine follow-up visits through 3 years after enrollment
Number of headache attacks occurring during a 7-day period, assessed from headache diary data when available or from clinical history collected at study visits. Values will be recorded according to the participant's trigeminal autonomic cephalalgia subtype.
Duration of individual headache attacks
Typical duration of headache attacks, expressed in minutes, assessed from headache diary data when available or from clinical history collected at study visits.
Headache attack pain intensity assessed using the 11-point Numerical Rating Scale
Pain intensity will be rated on an 11-point Numerical Rating Scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Number of participants with cranial autonomic symptoms
Number and percentage of participants reporting cranial autonomic symptoms associated with headache attacks. Symptom categories collected include lacrimation, conjunctival injection, nasal congestion, ptosis, and miosis.
Change from baseline in weekly attack frequency during preventive treatment
Change in the number of headache attacks per week from the pretreatment baseline value during preventive treatment.
Number of participants achieving at least a 50% reduction in weekly attack frequency
Number and percentage of participants with a reduction of at least 50% in weekly attack frequency compared with the pretreatment baseline value.
Change from baseline in days per week requiring acute headache medication
Change in the number of days per week on which acute headache medication is used compared with the pretreatment baseline value.
Number of participants achieving sustained attack remission
Number and percentage of participants experiencing at least 3 consecutive months without headache attacks.
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Lead sponsor
University of Modena and Reggio Emilia
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Università degli Studi dell'Aquila
Collaborator
University of Roma La Sapienza
Collaborator
Pavia IRCCS Mondino di Pavia
Collaborator
