跳至主要内容
临床试验/NCT06229002
NCT06229002招募中不适用

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

Hôpital le Vinatier2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
2
主要终点
Area under the curve (AUC) of the cortisol secretion after the stress task.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants and experimenters (including α-tACS operator) will not be informed about the nature (active or placebo) of the stimulation they will receive

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Active tACS stimulation

Experimental

Transcranial alternative current stimulation (tACS) at alpha frequency Single session of tACS : 30 minutes, 2mA, frequency = 10Hz, both electrodes located on the dorsolateral prefrontal cortex (left and right)

干预措施: Transcranial alternative current stimulation (tACS) at alpha frequency (Procedure)

Sham stimulation

Placebo Comparator

Single session of tACS sham stimulation : both electrodes located on the dorsolateral prefrontal cortex (left and right) ; real current delivered for the first and last 30s of the total stimulation time (ramp-in and ramp-out)

干预措施: Sham stimulation (Procedure)

结局指标

主要结局

Area under the curve (AUC) of the cortisol secretion after the stress task.

时间窗: 1 day

Samples of salivary cortisol will be repeatedly (10 occurences) collected during the experiment. The collection will take place before, during and after the stress task.

次要结局

  • Effect of α-tACS on the asymmetry of the alpha band (AFα) in stressed healthy subjects(1 day)
  • Effect of α-tACS on source monitoring in stressed healthy subjects(1 day)
  • Effect of α-tACS on the cortisol awakening response in stressed healthy subjects(4 days)
  • Effect of α-tACS on the beta band in stressed healthy subjects(1 day)
  • Effect of α-tACS on time perception in stressed healthy subjects(1 day)
  • Effect of α-tACS on impulsivity in stressed healthy subjects(1 day)
  • Effect of α-tACS on the molecular reactivity to stress(1 day)

研究者

发起方
Hôpital le Vinatier
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Effect of Transcranial Alternative Current... | 临床试验