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Default Mode Network Connectivity and Nocebo Responses in Migraine: A Functional MRI Study (Does not exist)

17 juillet 2026 mis à jour par: Ioanna Spanou

People with migraine sometimes experience symptoms because they expect a treatment to cause side effects. This is known as the "nocebo effect". Unlike a drug side effect, a nocebo effect is triggered by negative expectations rather than by the treatment itself. Nocebo effects can reduce patients' confidence in treatment and may lead them to stop taking medications that could help control their migraine. Understanding why some people are more likely to experience nocebo effects could help healthcare professionals improve treatment discussions and support long-term treatment adherence.

The aim of this study was to investigate whether changes in brain activity are associated with nocebo responses in people with migraine. Researchers focused on the "default mode network" (DMN), a group of interconnected brain regions involved in self-reflection, emotions, memory, and expectations. Because expectations play an important role in nocebo effects, the researchers examined whether communication within this brain network changed during a nocebo challenge.

Forty adults with migraine were recruited from the Headache Clinic of Aeginition Hospital, National and Kapodistrian University of Athens, between October 2019 and February 2023. All participants underwent magnetic resonance imaging (MRI) and resting-state functional MRI (rs-fMRI), a technique that measures communication between brain regions while a person is resting. Participants were then randomly assigned to one of three groups. One group received an intravenous saline infusion together with the suggestion that they might experience numbness. A second group received only the same verbal suggestion, without the saline infusion. A third group received no intervention. Thirty minutes later, participants reported whether they had experienced numbness before undergoing a second brain scan. Participants also completed a questionnaire measuring their susceptibility to nocebo effects. Four participants were excluded because excessive movement affected the quality of their MRI scans, leaving 36 participants for the final analysis.

This study investigated whether changes in DMN connectivity were associated with the nocebo challenge and whether these changes differed between participants who did and did not report numbness. By identifying brain mechanisms involved in nocebo responses, this research may improve our understanding of why some people are more susceptible than others. Although the study was exploratory and included a relatively small number of participants, its findings may contribute to future strategies that help clinicians identify patients at greater risk of nocebo responses, communicate more effectively about treatment, and improve adherence to migraine therapies. Larger studies are needed to confirm these findings before they can be applied in routine clinical practice.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Athens, Grèce, 11528
        • 1st Neurogy Department, Aeginition Hospital, National and Kapodistrian Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • Diagnosis of migraine (ICHD-3)
  • Age 18-55 years
  • Right-handedness
  • Be able to read and sign written informed consent in Greek
  • Absence of migraine attack during the experiment

Exclusion Criteria:

  • Diagnosis of chronic migraine
  • Cognitive disorders requiring medication
  • Pregnancy or breastfeeding
  • Presence of any metallic objects in the eyes or central nervous system
  • Implanted metallic or electronic devices (e.g. cardiac pacemaker, metallic cardiac valve, cochlear implant, orthopedic implants
  • History of claustrophobia
  • Use of prophylactic anti-migraine treatment during recruitment

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Autre
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Arm 1: Enhanced nocebo challenge
An intravenous "contrast agent" (10 ml of normal saline 0.9%) was administrated, and participants were informed that they will be given an intravenous "contrast agent", needed for the second rs- fMRI scan, that may numb one side of their body
An intravenous "contrast agent" (10 ml of normal saline 0.9%) was administrated, and participants were informed that they will be given an intravenous "contrast agent", needed for the second rs- fMRI scan, that may numb one side of their body.
Expérimental: Arm 2 : Verbal nocebo challenge
Participants did not receive any "contrast agent", but were informed that during the second fMRI scan, "they may feel numbness", thus they received negative verbal suggestion only
Participants did not receive any "contrast agent", but were informed that during the second fMRI scan, "they may feel numbness", thus they received negative verbal suggestion only.
Expérimental: Arm 3 : No challenge
This group did not receive any "contrast agent" or negative verbal suggestion
This group did not receive any "contrast agent" or negative verbal suggestion

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Functional Connectivity (FC) changes within Default Mode Network (DMN)-related regions both interictally and during an anxiety-mediated nocebo challenge
Délai: A 2nd resting- state functional Magnetic Resonance Imaging (rs- fMRI) scan was performed 30 minutes after the 1st rs- fMRI scan.
All functional and anatomical 3D high-resolution (HR)-T1-weighted images were preprocessed using the CONN toolbox and Statistical Parametric Mapping 12. The primary aim of this exploratory study was to investigate hypothesis-driven functional connectivity changes using a seed-based approach focused on specific DMN regions of interest. We examined connectivity among predefined DMN seed regions, which were defined using the default atlas implemented in the CONN toolbox. Four core DMN seeds were selected: the posterior cingulate cortex (PCC; MNI/Montreal Neurological Institute space -1, -61, 38), the medial prefrontal cortex (MPFC; MNI 1, 55, -3), the left lateral parietal cortex (LP; MNI -39, -77, 33), and the right lateral parietal cortex (LP; MNI 47, -67, 29). Each seed region was defined as a 6-mm radius sphere centered on the respective MNI coordinates, in line with standard CONN preprocessing defaults, to ensure the reproducibility of the seed-based connectivity analyses.
A 2nd resting- state functional Magnetic Resonance Imaging (rs- fMRI) scan was performed 30 minutes after the 1st rs- fMRI scan.

Collaborateurs et enquêteurs

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Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

22 octobre 2019

Achèvement primaire (Réel)

22 octobre 2023

Achèvement de l'étude (Réel)

22 octobre 2023

Dates d'inscription aux études

Première soumission

12 juillet 2026

Première soumission répondant aux critères de contrôle qualité

17 juillet 2026

Première publication (Réel)

22 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

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Description du régime IPD

study protocol patient's informed consent

Délai de partage IPD

Beginning 3 months and ending 3 years after the publication of results

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

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Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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