NCT07617441Recruiting
The Neuroanatomical and Psychological Correlates of Suggestibility in Patients With Non-Responsive Chronic Migraine
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
Chronic migraine is a disabling neurovascular disorder and one of the leading causes of years lived with disability worldwide. Population-based studies report a worrying level of resistance to currently available treatments in clinical practice. For this reason, the clinical and scientific community is increasingly investigating new therapeutic approaches aimed at reducing the burden of symptoms and improving patients' quality of life. Among the alternative therapeutic approaches explored in migraine research, the placebo effect has emerged as a potentially important mechanism. However, the duration and intensity of its beneficial effects on migraine symptoms are still poorly understood. In particular, there is a need to identify biological and clinical markers that may predict which patients are more likely to benefit from placebo-related mechanisms. One of the most promising factors is suggestibility, namely the tendency of an individual to respond to suggestions, expectations, or contextual influences. It is possible that patients with non-responsive chronic migraine may show different levels of suggestibility, which could influence the effectiveness of placebo-related responses. To investigate this hypothesis, it is first necessary to better understand the psychobiological characteristics of patients with non-responsive chronic migraine (NRCM). Therefore, the primary aim of this monocentric observational study is to characterize the neurobiological and psychological profile of individuals affected by NRCM through advanced magnetic resonance imaging techniques (connectomics) and a comprehensive battery of psychodiagnostic assessments, including the evaluation of suggestibility. The study plans to recruit at least 100 patients with NRCM and 100 healthy control subjects matched for age and sex. By comparing participants with high and low levels of suggestibility, the study aims to identify new neurobiological profiles (bio-phenotypes) associated with these characteristics. These findings may contribute to future research on the placebo effect and help develop more personalized treatment strategies for patients with chronic migraine who do not respond to conventional therapies.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 21 May 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Diseases
- Migraine
- NCT number
- NCT07617441
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Jul 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- affected by concomitant neurological, cardiovascular, or cerebrovascular diseases;
Other illness
- history of alcohol or substance abuse;
- liver disease or kidney disease;
- psychiatric disorders (psychosis, major depression, bipolar disorder).
- diagnosis or history of migraine (for healthy subjects).
Age
- older than 75 years;
Other
- children
- pregnant or breastfeeding women;
Who the study is looking for
- adults aged ≥ 18 years and ≤ 75 years;
- diagnosis of non-responsive chronic migraine (NRCM) according to ICHD-3 beta criteria;
- presence of at least 8 migraine days per month associated with disability (MIDAS ≥ 11), and insufficient response after 6 weeks or inability to tolerate at least three previously prescribed migraine preventive agents, i.e., resistance to standard therapy for at least 6 weeks;
- signed informed consent.
- adults aged ≥ 18 years and not older than 75 years;
- absence of a diagnosis of NRCM according to ICHD3beta or other relevant -neurological disorders as assessed during the medical history taken at the headache center;
- signed informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renato Dulbecco University Hospital Coordinator of this site? Confirm its status | Catanzaro | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.