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Идёт набор NCT07369908

The Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Anxiety Responses and Emotional Regulation

Без фазы С лечением Healthy Male and Female Volunteers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: taVNS on tragus of subjects with high trait anxiety, taVNS on earlobe of subjects with high trait anxiety, taVNS on tragus of subjects with no high trait anxiety, taVNS on earlobe of subjects with no high trait anxiety.
Кому может быть актуально
Состояния в реестре: Healthy Male and Female Volunteers. Базовые параметры: 18 лет — 30 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
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Следующий шаг
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Официальное название

The Modulatory Effects of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) on Anxiety Responses and Emotional Regulation

Обзор

The main aim of this study is to investigate whether transcutaneous auricular vagus nerve stimulation (taVNS) can reduce anxiety and have an effect on emotional regulations

Подробное описание

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive method for modulating vagal nerve function and has shown potential efficacy in alleviating anxiety symptoms and improving emotional regulation. But the neural mechanisms of how taVNS affects anxiety and emotional regulation remain unclear. Therefore, we focus on this question by combining behavioral meausres, skin conductance response, heart rate variability and fMRI in this study. A participant-blinded, sham-controlled, between-subject design is employed in this study. In a randomised order, a total of 140 healthy males and females with or without high trait anxiety are recruited and receive the stimulation of taVNS on their tragus (experimental group) or earlobe (sham control group). After the participants arrive at the laboratory, they first complete a roughly 30-minute personality trait questionnaire and prepare for the experiment. Then, they undergo a 7-minute resting-state fMRI scan, followed by a 15-minute taVNS session. Next, they complete a 7-minute resting-state scan and a 60-minute task-based scan (a modified emotional regulation task). During the entire procedure, saliva samples will be collected three times for subsequent physiological hormone analyses, and participants' skin conductance and electrocardiogram data will also be recorded. During the modified emotional regulation task, subjects are instructed to regulate their emotional responses to negative pictures (high vs. low intensity) using reinterpretation/distance strategies or to only look these pictures. We also record subjects' rating scores on their anxiety levels during these conditions ("reinterpretation" vs. "distance" vs. "look") and successful usage of emotional regulation strategies. Questionnaire scores including State-Trait Anxiety Inventory, Beck Depression Inventory II, Beck Anxiety Inventory, Autism Spectrum Quotient, Toronto Alexithymia Scale, Social Responsiveness Scale, Emotion Regulation Questionnaire, Cognitive Emotion Regulation Questionnaire, Multidimensional Assessment of Interoceptive Awareness, Positive and Negative Affect Schedule will also be collected.

Вмешательства

  • Устройство taVNS on tragus of subjects with high trait anxiety
    15 minutes taVNS on tragus
  • Устройство taVNS on earlobe of subjects with high trait anxiety
    15 minutes taVNS on earlobe
  • Устройство taVNS on tragus of subjects with no high trait anxiety
    15 minutes taVNS on tragus
  • Устройство taVNS on earlobe of subjects with no high trait anxiety
    15 minutes taVNS on earlobe

Первичные конечные точки

  • Brain activity patterns in response to negative pictures during emotional regulation [Срок оценки: 60 minutes]
  • Resting-state functional conetivity changes [Срок оценки: 15 minutes]
  • Behavioral indices in the task [Срок оценки: 60 minutes]
Вторичные конечные точки (3)
  • Skin conductance responses (SCR) in the emotional regulation task during fMRI scanning [Срок оценки: 60 minutes]
  • HRV in resting-state fMRI and emotional regulation task [Срок оценки: 75 minutes during scanning]
  • Saliva samples analysis [Срок оценки: Three time points: pre-taVNS (baseline, 0 minute), immediate post-taVNS (60 minutes post-taVNS), and the end of experiment (70 minutes post-scanning).]

Критерии участия

Критерии включения

  • Healthy subjects without past or current psychiatric or neurological disorders.

Критерии исключения

  • History of head injury.
  • Medical or psychiatric illness.
  • Subjects take a certain drug for a long period of time.
  • Subjects have metal implants in their bodies.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Китай · 1 центр
  • University of Electronic Science and Technology of China (UESTC) — Чэнду

Идентификаторы

NCT: NCT07369908 · UESTC-neuSCAN-97

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗