Studio TIARA: Alessitimia ed Emicrania Cronica

NCT06891053 | Enrolling By Invitation

• 1 other identifier: Asl22.Neuro.22.01
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this observational, cross-sectional study is to investigate the relationship between alexithymia and migraine frequency (considering alexithymia a condition that can influence the severity of the clinical phenotype of migraine, favoring its chronicization), in an analysis adjusted for psychiatric comorbidity (for anxiety and depression, potentially influencing migraine chronicization) and for personalogical factor represented by apathy.

Conditions

Migraine; Alexithymia

Outcome Measures

Primary Outcomes (2)

• Degree of alexithymia

  Independent variable measured as a score on the TAS-20 scale

  In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval

• Migraine frequency

  In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval

Secondary Outcomes (2)

• Number of "drug days" in patients diagnosed with MOH

  In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval

• Degree of alessithymia in patients diagnosed with MOH

  In 3 periods of 30 days each (3 months), which make up the 90-day observation time interval

Study Arms (1)

Diagnosis of episodic migraine without or with aura, chronic migraine, and/or MOH

Female patients, aged 12-65 years, diagnosed with episodic migraine without or with aura, chronic migraine, and/or MOH according to the criteria of ICHD-3 2018

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients, aged 12-65 years, diagnosed with episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria

You may qualify if:

• Diagnosis of episodic migraine with or without aura, chronic migraine and/or MOH according to ICHD-3 2018 criteria;
• Patients aged 12-65 years;
• Female patients

You may not qualify if:

• Ongoing major depressive episode;
• Comorbidities for major internal diseases (hepatopathy, nephropathy, heart failure, etc.);
• Alcohol or substance abuse disorder (eoin, cocaine, cannabis, hallucinogens);
• Language barrier;
• Low cultural/cognitive level;
• No informed consent.

Sponsors & Collaborators

• Azienda Sanitaria Locale di Alessandria: lead

Study Sites (1)

Azienda Sanitaria Locale di Alessandria (ASL AL)

Alessandria, Italy, 15121, Italy

Location

MeSH Terms

Conditions

Migraine Disorders; Affective Symptoms

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Eugenia Rota

  Azienda Sanitaria Locale di Alessandria (ASL AL)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 24, 2025
• Study Start: May 30, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 31, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)