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Headache study digs into brain and personality to improve treatment

NCT ID NCT07268768

Knowledge-focused Sponsor: IRCCS Centro Neurolesi Bonino Pulejo Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how thinking skills, personality, and pain sensitivity affect headache treatment in 64 adults with chronic or episodic headaches. Researchers will track participants for about six months to understand what helps or hinders treatment success. The goal is to find better ways to manage headaches and improve quality of life.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age between 18 and 60 years; * Diagnosis of chronic or episodic headache; * Patients attending the Headache Outpatient Clinic. Exclusion Criteria: * Presence of severe psychiatric and neurological disorders; * Presence of oncological diseases in terminal stage

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Conditions

The condition(s) this trial relates to.

anxiety disorder Bronchiolitis Obliterans Syndrome Cognitive Dysfunction Depression headache disorder Personality Disorders Treatment Adherence and Compliance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic and episodic headache Headache disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Irccs Centro Neurolesi Bonino Pulejo

    RECRUITING

    Messina, Sicily, 98066, Italy

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