PERSONOLOGICAL STRUCTURE, COGNITIVE FUNCTIONS AND CENTRAL SENSITIZATION IN HEADACHE

NCT07268768 | Recruiting DMC

• 1 other identifier: CEL/U117/25
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Headache, in its episodic and chronic forms, cannot be considered solely as an isolated neurological symptom, but as a complex condition of a bio-psycho-social nature. While in the episodic form the painful episodes occur intermittently and have a variable impact on daily life, in the chronic form the disease evolves towards persistent pain, with more significant consequences on personal, social and work functioning. The following study protocol aims to investigate in an integrated manner the neurological, cognitive and psychological mechanisms involved in headache, with particular attention to the differences between episodic and chronic forms. The main objective is to assess the neuropsychological profiles and pain response of patients, monitoring their evolution over a period of approximately six months, considering the impact of central sensitisation, personality structure and any psychopathological comorbidities on pain management and treatment adherence. The protocol adopts a multidimensional approach aimed at optimising therapeutic efficacy and improving patients' quality of life, preventing progression to chronicity.

Conditions

Chronic and Episodic Headache; Headache Disorders

Keywords

chronic migraine; central sensitization; cognitive impairment; personality disorders; treatment adherence; anxiety; depression;

Outcome Measures

Primary Outcomes (1)

• Neuropsychological assessment

  •Cognitive functions: Brief Cognitive Status Exam (BCSE) and/or Montreal Cognitive Assessment (MoCA)

  6 months

Secondary Outcomes (1)

• Central sensitization

  6 months

Study Arms (2)

Chronic headache

Patients suffering from chronic headache

Other: Neuropsychological assessment

Episodic headache

Patients suffering from episodic headache

Other: Neuropsychological assessment

Interventions

Neuropsychological assessment OTHER

Standardized and ad hoc test battery for comprehensive neuropsychological assessment

Chronic headache; Episodic headache

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target population consists of adult patients with a diagnosis of chronic or episodic headache referring to the Headache Outpatient Clinic. Sample size was calculated using G\*Power 3.1, taking as reference the primary objective of comparing the evolution (baseline vs T1) of main clinical-neuropsychological outcomes between chronic and episodic headache groups. The primary test was modeled as a repeated-measures ANOVA on the group×time interaction (two groups, two measurements), analogous to the interaction component of a linear mixed model. With a significance level α = 0.05, statistical power 1-β = 0.90, intra-subject correlation r = 0.60 and two measurements, assuming an interaction effect size f = 0.20 and nonsphericity correction ε = 1, the minimum required sample size is N = 56 subjects (28 per group). Taking into account an expected dropout rate of 15%, the required enrollment was increased to N = 64 participants (32 per group), in order to preserve the planned power for the p

You may qualify if:

• Age between 18 and 60 years;
• Diagnosis of chronic or episodic headache;
• Patients attending the Headache Outpatient Clinic.

You may not qualify if:

• Presence of severe psychiatric and neurological disorders;
• Presence of oncological diseases in terminal stage

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

Irccs Centro Neurolesi Bonino Pulejo

Messina, Sicily, 98066, Italy

RECRUITING

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome; Headache Disorders; Cognitive Dysfunction; Personality Disorders; Treatment Adherence and Compliance; Anxiety Disorders; Depression

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Health Behavior; Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Anna Anselmo, Psychologist

CONTACT

3489266543; anna.anselmo@irccsme.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 8, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): November 20, 2028
• Study Completion (Estimated): November 20, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)