PERSONOLOGICAL STRUCTURE, COGNITIVE FUNCTIONS AND CENTRAL SENSITIZATION IN HEADACHE

ConditionsChronic and Episodic Headache Headache Disorders

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-60

SponsorIRCCS Centro Neurolesi Bonino Pulejo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 60 years;

Diagnosis of chronic or episodic headache;

Patients attending the Headache Outpatient Clinic.

Disqualifiers

Presence of severe psychiatric and neurological disorders;

Presence of oncological diseases in terminal stage

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Neuropsychological assessment
Other intervention
Standardized and ad hoc test battery for comprehensive neuropsychological assessment

Treatment groups

64 Participants

are divided into 2 treatment groups

Group A: Chronic headache1 intervention

Group B: Episodic headache1 intervention

Trial outcomes

Primary outcomes

Neuropsychological assessment

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

Time frame

6 months

Secondary outcomes

Central sensitization

Central Sensitization Inventory (CSI)

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IRCCS Centro Neurolesi Bonino Pulejo

Lead sponsor

Source ClinicalTrials.gov

Apply now