Clinical trial NCT06229002: Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects
Official title: Biological, Neuropsychological and Electrophysiological Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled, randomized parallel arms study including 40 healthy participants who will receive active and placebo α-tACS
Primary purpose: BASIC_SCIENCE

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Area under the curve (AUC) of the cortisol secretion after the stress task.
timeFrame: 1 day
Secondary outcomes:
measure: Effect of α-tACS on the cortisol awakening response in stressed healthy subjects
timeFrame: 4 days
measure: Effect of α-tACS on the molecular reactivity to stress
timeFrame: 1 day
measure: Effect of α-tACS on the molecular reactivity to stress
timeFrame: 1 day
measure: Effect of α-tACS on the molecular reactivity to stress
timeFrame: 1 day
measure: Effect of α-tACS on the molecular reactivity to stress
timeFrame: 1 day
measure: Effect of α-tACS on the molecular reactivity to stress
timeFrame: 1 day
measure: Effect of α-tACS on the molecular reactivity to stress
timeFrame: 1 day
measure: Effect of α-tACS on the molecular reactivity to stress
timeFrame: 1 day
measure: Effect of α-tACS on the asymmetry of the alpha band (AFα) in stressed healthy subjects
timeFrame: 1 day
measure: Effect of α-tACS on the beta band in stressed healthy subjects
timeFrame: 1 day
measure: Effect of α-tACS on source monitoring in stressed healthy subjects
timeFrame: 1 day
measure: Effect of α-tACS on impulsivity in stressed healthy subjects
timeFrame: 1 day
measure: Effect of α-tACS on time perception in stressed healthy subjects
timeFrame: 1 day
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier Le Vinatier
state: Aura
Study officials:
References: