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

NCT ID: NCT06229002

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-24

Study Completion Date

2028-02-01

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, placebo-controlled, randomized parallel arms study including 40 healthy participants who will receive active and placebo α-tACS
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

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

Study Groups

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Active tACS stimulation

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)

Group Type EXPERIMENTAL

Transcranial alternative current stimulation (tACS) at alpha frequency

Intervention Type PROCEDURE

Single session of tACS

Sham stimulation

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)

Group Type PLACEBO_COMPARATOR

Sham stimulation

Intervention Type PROCEDURE

Single session of tACS sham stimulation

Interventions

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Transcranial alternative current stimulation (tACS) at alpha frequency

Single session of tACS

Intervention Type PROCEDURE

Sham stimulation

Single session of tACS sham stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Le Vinatier

Bron, AURA, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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POULET EMMANUEL, PUPH

Role: primary

0033437915120 ext. +33

SARTELET Lydie

Role: backup

0033437915531

Other Identifiers

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2023-A01368-37

Identifier Type: -

Identifier Source: org_study_id

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