Chronic Migraine HeadacheSIGMANCT07617441
The Neuroanatomical and Psychological Correlates of Suggestibility in Patients With Non-Responsive Chronic Migraine
An observational study of Chronic Migraine Headache, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine Headache
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2026to May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of patients with non-responsive chronic migraine ( NRCM ) attending the Headache Centre of the "Pugliese-Ciaccio" Hospital in Catanzaro, Italy. In parallel, healthy control subjects matched for age and sex will be recruited from the general population, residing in or domiciled in the Calabria region, through institutional advertisements and communications from the Headache and Adaptive Disorders Centre of the same hospital. All participants will undergo clinical screening and, if eligible, will be further assessed at the clinical and neuroimaging facilities involved in the study, including the neuroimaging unit of the IBSBC-CNR located at the "Mater Domini" Hospital in Catanzaro, Italy.
Who may be able to join
- 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.
Who cannot join
- older than 75 years;
- children
- pregnant or breastfeeding women;
- history of alcohol or substance abuse;
- affected by concomitant neurological, cardiovascular, or cerebrovascular diseases;
- liver disease or kidney disease;
- psychiatric disorders (psychosis, major depression, bipolar disorder).
- diagnosis or history of migraine (for healthy subjects).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Renato Dulbecco University Hospital
Catanzaro, Catanzaro, 88100
Domenico Bosco, Medical Doctor, 0961/883021, nico_bosco@libero.it
About this study
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.
Read more
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.
- Conditions
- Chronic Migraine Headache
- Keywords
- Chronic migraine, Suggestibility, Placebo effect, Connectomics, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| **Patients with Non-Responsive Chronic Migraine (NRCM)** | Not described | |
| Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suggestibility levels in chronic migraine
Participants will be categorized into high- and low-suggestibility groups using K-means clustering based on Multidimensional Iowa Suggestibility Scale (MISS) scores.
Measured: Baseline (single assessment at enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Renato Dulbecco
- Responsible party
- Principal investigator, Antonio Cerasa, Istituto per la Ricerca e l'Innovazione Biomedica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617441
- Sponsor's protocol ID
- 27/2026
- Acronym
- SIGMA
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neuroanatomical and Psychological Correlates of Suggestibility in Patients With Non-Responsive Chronic Migraine
- ClinicalTrials.gov ID
- NCT07617441
- Acronym / sponsor ID
- SIGMA / 27/2026
- Conditions
- Chronic Migraine Headache
- Keywords
- Chronic migraine, Suggestibility, Placebo effect, Connectomics, Biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Renato Dulbecco
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| **Patients with Non-Responsive Chronic Migraine (NRCM)** | – | – |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients with non-responsive chronic migraine ( NRCM ) attending the Headache Centre of the "Pugliese-Ciaccio" Hospital in Catanzaro, Italy. In parallel, healthy control subjects matched for age and sex will be recruited from the general population, residing in or domiciled in the Calabria region, through institutional advertisements and communications from the Headache and Adaptive Disorders Centre of the same hospital. All participants will undergo clinical screening and, if eligible, will be further assessed at the clinical and neuroimaging facilities involved in the study, including the neuroimaging unit of the IBSBC-CNR located at the "Mater Domini" Hospital in Catanzaro, Italy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- older than 75 years;
- children
- pregnant or breastfeeding women;
- history of alcohol or substance abuse;
- affected by concomitant neurological, cardiovascular, or cerebrovascular diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Suggestibility levels in chronic migraine
Time frame: Baseline (single assessment at enrollment)
Participants will be categorized into high- and low-suggestibility groups using K-means clustering based on Multidimensional Iowa Suggestibility Scale (MISS) scores.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Migraine Headache, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Domenico Bosco, Medical Doctor (0961/883021, nico_bosco@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suggestibility levels in chronic migraine (time frame: Baseline (single assessment at enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.