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Идёт набор NCT06229002

Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects

Без фазы С лечением Healthy

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: Transcranial alternative current stimulation (tACS) at alpha frequency, Sham stimulation.
Кому может быть актуально
Состояния в реестре: Healthy. Базовые параметры: 18 лет — 45 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Biological, Neuropsychological and Electrophysiological Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects

Обзор

stress. Notably, several studies reported that stress could alter impulsivity, source monitoring, and time perception. Several mechanisms are involved in the response to a stress factor, among them the hypothalamic-pituitary-adrenal (HPA) axis. The cortisol reactivity (it means the cortisol secretion after the exposure to a standardized stress factor) is a reliable tool to assess the function of HPA. Cortisol secretion is bidirectionally influenced by the prefrontal cortex (PFC), which is involved in the expression and regulation of stress as well. The asymmetry of the alpha band (AFα) is a well known electrophysiological parameter to assess the function of PFC. More precisely, AFα is arising a growing interest, as it is believed to be correlated with the cortisol reactivity. Modifying this asymmetry could influence the stress response. Transcranial Alternating Current Stimulation (tACS) consists in delivering a sinusoidal alternating current between two electrodes placed on the scalp at a predefined frequency. Previous studious reported that tACS, if delivered at the alpha frequency, increased the alpha band in the stimulated areas

Подробное описание

The study will focus on the effect of tACS at alpha frequency (α-tACS), delivered on the dorsolateral prefrontal cortex, on the response to a stress factor.

In this study, while receiving a single α-tACS session, the participants will complete a standardized stress test combining cognitive stress (mental calculation) and physical stress (cold pressure): the Maastricht Acute Stress Test. The main objective aims at assessing the effect of a single session of tACS at alpha frequency, delivered on the dorsolateral prefrontal cortex, on the cortisol reactivity in healthy stressed subjects. In that study, the influence of α-tACS on other biological ; electrophysiological, neuropsychological parameters relevant for the stress response will be assessed also.

Вмешательства

  • Процедура Transcranial alternative current stimulation (tACS) at alpha frequency
    Single session of tACS
  • Процедура Sham stimulation
    Single session of tACS sham stimulation

Первичные конечные точки

  • Area under the curve (AUC) of the cortisol secretion after the stress task. [Срок оценки: 1 day]
Вторичные конечные точки (12)
  • Effect of α-tACS on the cortisol awakening response in stressed healthy subjects [Срок оценки: 4 days]
  • Effect of α-tACS on the molecular reactivity to stress [Срок оценки: 1 day]
  • Effect of α-tACS on the molecular reactivity to stress [Срок оценки: 1 day]
  • Effect of α-tACS on the molecular reactivity to stress [Срок оценки: 1 day]
  • Effect of α-tACS on the molecular reactivity to stress [Срок оценки: 1 day]
  • Effect of α-tACS on the molecular reactivity to stress [Срок оценки: 1 day]
  • Effect of α-tACS on the molecular reactivity to stress [Срок оценки: 1 day]
  • Effect of α-tACS on the molecular reactivity to stress [Срок оценки: 1 day]
  • Effect of α-tACS on the asymmetry of the alpha band (AFα) in stressed healthy subjects [Срок оценки: 1 day]
  • Effect of α-tACS on the beta band in stressed healthy subjects [Срок оценки: 1 day]
  • Effect of α-tACS on source monitoring in stressed healthy subjects [Срок оценки: 1 day]
  • Effect of α-tACS on impulsivity in stressed healthy subjects [Срок оценки: 1 day]

Критерии участия

Критерии включения

  • Right-handed Men and Women aged between 18 and 45
  • If woman, hormonal contraception required
  • Having given their written informed consent
  • Affiliated with a social security scheme
  • French speakers and readers

Критерии исключения

  • Contraindication to the exposure to exposure to tACS
  • Current psychiatric disorder as classified in the DSM-5
  • Regular intake of any psychotropic drug or Beta Blocker
  • Recent exposure to a traumatic event
  • Any debilitating condition making the experimental procedure not feasible
  • Pregnancy

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
Тройное слепое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • Centre Hospitalier Le Vinatier — Bron

Идентификаторы

NCT: NCT06229002 · 2023-A01368-37

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗