Actively Recruiting
The Neuroanatomical and Psychological Correlates of Suggestibility in Patients With Non-Responsive Chronic Migraine
Led by Istituto per la Ricerca e l'Innovazione Biomedica · Updated on 2026-06-01
200
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
I
Istituto per la Ricerca e l'Innovazione Biomedica
Lead Sponsor
A
Azienda Ospedaliera Universitaria Renato Dulbecco
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic migraine is a disabling neurovascular disorder that often resists current treatments, leading researchers to explore new therapeutic approaches to lessen symptoms and improve quality of life. This study focuses on understanding the role of suggestibility, or how patients respond to expectations and contextual influences, in non-responsive chronic migraine (NRCM). It aims to identify neurobiological and psychological profiles that may predict which patients benefit from placebo effects. The study is observational and plans to recruit at least 100 patients with NRCM and 100 healthy control subjects matched by age and sex. It will use advanced magnetic resonance imaging (connectomics) alongside a detailed set of psychological tests to assess suggestibility and other psychobiological traits. Participants are divided into two groups: those with non-responsive chronic migraine and healthy controls. Participants will undergo a single baseline assessment to measure suggestibility levels and undergo neuroimaging and psychodiagnostic evaluations. Researchers will compare profiles between individuals with high and low suggestibility to identify distinct bio-phenotypes. The study will monitor participants over the course of the trial, which runs until May 2029, to better understand placebo mechanisms and inform personalized treatments.
CONDITIONS
Brief Title
The Neuroanatomical and Psychological Correlates of Suggestibility in Patients With Non-Responsive Chronic Migraine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosis of non-responsive chronic migraine (NRCM) according to ICHD-3 beta criteria
- At least 8 migraine days per month causing disability (MIDAS 6 11)
- Insufficient response or intolerance to at least three migraine preventive treatments for 6 weeks or more
- Signed informed consent
- Adults aged 18 to 75 years without NRCM or relevant neurological disorders for healthy subjects
- Signed informed consent for healthy subjects
You will not qualify if you...
- Older than 75 years
- Children
- Pregnant or breastfeeding women
- History of alcohol or substance abuse
- Concomitant neurological, cardiovascular, or cerebrovascular diseases
- Liver or kidney disease
- Psychiatric disorders such as psychosis, major depression, bipolar disorder
- Diagnosis or history of migraine for healthy subjects
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment at enrollment
Participants undergo assessments to measure suggestibility levels and neuroanatomical and psychological characteristics.
1 visit (in-person)
Duration - Up to approximately 1 year
Participants are observed over time to monitor suggestibility and migraine characteristics without active intervention.
Visits as scheduled per study protocol
Trial Site Locations
Total: 1 location
1
Renato Dulbecco University Hospital
Catanzaro, Catanzaro, Italy, 88100
Actively Recruiting
Research Team
D
Domenico Bosco, Medical Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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