The Neuroanatomical and Psychological Correlates of Suggestibility in Patients With Non-Responsive Chronic Migraine (SIGMA)
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.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Domenico Bosco, Medical Doctor
- 電話番号：0961/883021
- メール：nico_bosco@libero.it
研究場所
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Catanzaro
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Catanzaro、Catanzaro、イタリア、88100
- 募集
- Renato Dulbecco University Hospital
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コンタクト：
- Domenico Bosco, Medical Doctor
- 電話番号：0961/883021
- メール：nico_bosco@libero.it
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria for Non-Responsive Chronic Migraine subjects:
- 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.
Inclusion Criteria for healthy subjects are:
- 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.
Exclusion Criteria:
- 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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
|---|
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健康管理
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**Patients with Non-Responsive Chronic Migraine (NRCM)**
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Suggestibility levels in chronic migraine
時間枠：Baseline (single assessment at enrollment)
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Participants will be categorized into high- and low-suggestibility groups using K-means clustering based on Multidimensional Iowa Suggestibility Scale (MISS) scores.
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Baseline (single assessment at enrollment)
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 27/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
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米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。