An observational study in Chronic and Episodic Headache and Headache Disorders, sponsored by IRCCS Centro Neurolesi Bonino Pulejo. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by IRCCS Centro Neurolesi Bonino Pulejo · Observational
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.
This is an observational, prospective study with two assessment timepoints: baseline (T0) and follow-up at approximately six months (T1). The overall duration of the project is estimated at about three years, including enrollment of all planned participants, completion of follow-up, data analysis and dissemination of results.
The study is conducted at the IRCCS Centro Neurolesi "Bonino-Pulejo" with UTIC P.O. "Piemonte" in Messina, Italy, within the Headache Outpatient Clinic.
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 primary analysis.
Inclusion criteria
Study procedures All potentially eligible subjects are informed about the aims and procedures of the study and are free to choose whether to participate. Only after the subject, or his/her legal representative, has agreed to participate and has signed the informed consent form, do the investigators proceed with the planned activities.
Clinical data for each subject are stored in a secure database accessible to study collaborators via personal credentials. After verifying the inclusion and exclusion criteria and obtaining informed consent, patients are formally enrolled and scheduled for the baseline assessment (T0).
Baseline visit (T0)
At T0, the following procedures are performed:
After the clinical assessment, a standardized battery of tests is administered to evaluate dimensions related to chronic pain and quality of life:
Follow-up visit (T1) At approximately six months (T1), patients return for follow-up. All standardized instruments administered at T0 are readministered in order to evaluate changes over time in cognitive functioning, pain intensity and sensitization, personality and psychopathological dimensions, treatment adherence and digital habits.
714 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 128 are open to participants now.
This study's planned enrollment of 64 is below the median of 108 across 126 observational studies indexed under Bronchiolitis Obliterans Syndrome.
Browse Bronchiolitis Obliterans Syndrome studies →IRCCS Centro Neurolesi Bonino Pulejo is the lead sponsor of 67 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients suffering from chronic headache
Other: Neuropsychological assessment
Patients suffering from episodic headache
Other: Neuropsychological assessment
Standardized and ad hoc test battery for comprehensive neuropsychological assessment
Neuropsychological assessment
•Cognitive functions: Brief Cognitive Status Exam (BCSE) and/or Montreal Cognitive Assessment (MoCA)
Time frame: 6 months
Central sensitization
Central Sensitization Inventory (CSI)
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2028, 36 months after the start.
Of 49 non-industry observational studies under Bronchiolitis Obliterans Syndrome, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 75. This study's planned 36 months is below that.
Counting every sponsor, half of 57 studies reached it within 40 months; a quarter within 20 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
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Bronchiolitis Obliterans Syndrome →
IRCCS Centro Neurolesi Bonino Pulejo