Default Mode Network Connectivity and Nocebo Responses in Migraine: A Functional MRI Study (Does not exist)
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.
研究概览
地位
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Athens、希腊、11528
- 1st Neurogy Department, Aeginition Hospital, National and Kapodistrian Hospital
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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
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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.
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实验性的: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
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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.
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实验性的:Arm 3 : No challenge
This group did not receive any "contrast agent" or negative verbal suggestion
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This group did not receive any "contrast agent" or negative verbal suggestion
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Functional Connectivity (FC) changes within Default Mode Network (DMN)-related regions both interictally and during an anxiety-mediated nocebo challenge
大体时间:A 2nd resting- state functional Magnetic Resonance Imaging (rs- fMRI) scan was performed 30 minutes after the 1st rs- fMRI scan.
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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.
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A 2nd resting- state functional Magnetic Resonance Imaging (rs- fMRI) scan was performed 30 minutes after the 1st rs- fMRI scan.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 905/05-12-2018
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
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研究美国 FDA 监管的设备产品
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