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Recruiting NCT06229002

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

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial alternative current stimulation (tACS) at alpha frequency, Sham stimulation.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

France · 1 center
  • Centre Hospitalier Le Vinatier — Bron

Identifiers

NCT: NCT06229002 · 2023-A01368-37

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗