An interventional study of Transcranial alternative current stimulation (tACS) at alpha frequency and Sham stimulation in Healthy, sponsored by Hôpital le Vinatier. Recruiting at 1 site in France. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-07.
Sponsored by Hôpital le Vinatier · Not applicable, Interventional, and Basic science
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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
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.
Hôpital le Vinatier is the lead sponsor of 106 studies on the registry; 41 are open to participants now.
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Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Procedure: Transcranial alternative current stimulation (tACS) at alpha frequency
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)
Procedure: Sham stimulation
Single session of tACS
Single session of tACS sham stimulation
Area under the curve (AUC) of the cortisol secretion after the stress task.
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.
Time frame: 1 day
Effect of α-tACS on the cortisol awakening response in stressed healthy subjects
Samples of morning salivary cortisol will be collected repeatedly (3 times) before experimental session (including the stress task and the tACS session). A last sample of morning salivary cortisol will be collected the following day
Time frame: 4 days
Effect of α-tACS on the molecular reactivity to stress
The expression level of different proteins implicated in the intracellular communication channel after the couple cortisol-glucocorticoid receptor was formed (namely : NR3C1) will be assessed. A blood sample will be collected and the expression level of the relevant genes will be assessed by qPCR
Time frame: 1 day
Effect of α-tACS on the molecular reactivity to stress
The expression level of different proteins implicated in the intracellular communication channel after the couple cortisol-glucocorticoid receptor was formed (namely : FKBP4) will be assessed. A blood sample will be collected and the expression level of the relevant genes will be assessed by qPCR
Time frame: 1 day
Effect of α-tACS on the molecular reactivity to stress
The expression level of different proteins implicated in the intracellular communication channel after the couple cortisol-glucocorticoid receptor was formed (namely : FKBP5) will be assessed. A blood sample will be collected and the expression level of the relevant genes will be assessed by qPCR
Time frame: 1 day
Effect of α-tACS on the molecular reactivity to stress
The expression level of different proteins implicated in the intracellular communication channel after the couple cortisol-glucocorticoid receptor was formed (namely : BAG1) will be assessed. A blood sample will be collected and the expression level of the relevant genes will be assessed by qPCR
Time frame: 1 day
Effect of α-tACS on the molecular reactivity to stress
The expression level of different proteins implicated in the intracellular communication channel after the couple cortisol-glucocorticoid receptor was formed (namely : PTGES3) will be assessed. A blood sample will be collected and the expression level of the relevant genes will be assessed by qPCR
Time frame: 1 day
Effect of α-tACS on the molecular reactivity to stress
The expression level of different proteins implicated in the intracellular communication channel after the couple cortisol-glucocorticoid receptor was formed (namely : HSP90AA1) will be assessed. A blood sample will be collected and the expression level of the relevant genes will be assessed by qPCR
Time frame: 1 day
Effect of α-tACS on the molecular reactivity to stress
The expression level of different proteins implicated in the intracellular communication channel after the couple cortisol-glucocorticoid receptor was formed (namely : HSPA1A) will be assessed. A blood sample will be collected and the expression level of the relevant genes will be assessed by qPCR
Time frame: 1 day
Effect of α-tACS on the asymmetry of the alpha band (AFα) in stressed healthy subjects
AFα refers to the average difference in alpha-band activity (typically8-13 Hz) between the left and right frontal areas (F3- F7 versus F4-F8, respectively). For a 5-minute block, AFα will be assessed by EEG recording while the participant is at resting state and only requested to alternatively open and close the eyes, according to a standardized procedure
Time frame: 1 day
Effect of α-tACS on the beta band in stressed healthy subjects
The participant will have to complete the Kirby Delay Discounting Task (DDT). Subjects are presented with a series of hypothetical choices of amount of reinforcer to be had instantaneously, and a larger reinforcer available after a fixed delay. (For example : "Would you prefer 37€ today or 80€ in 60 days?" The outcome will be the change in the number of immediate choices between before and after the stress period (ΔDDT) express in percent
Time frame: 1 day
Effect of α-tACS on source monitoring in stressed healthy subjects
Source monitoring refers to the cognitive processes involved in making attributions about the origins of mental experiences (for example : was this mental experience dreamt?, imagined?, really perceived? If this was perceived, was it produced by myself or by anybody else?". Two subtypes of source monitoring will be tested : the reality monitoring (RM) and the internal monitoring (IM). In each task the participant will be confronted with a list of words he/she will have to determine the source of. The outcome will be the proportion of false attributions, expressed in percent
Time frame: 1 day
Effect of α-tACS on impulsivity in stressed healthy subjects
The participant will have to complete the Kirby Delay Discounting Task (DDT). Subjects are presented with a series of hypothetical choices of amount of reinforcer to be had instantaneously, and a larger reinforcer available after a fixed delay. (For example : "Would you prefer 37€ today or 80€ in 60 days?") The outcome will be the change in the number of immediate choices between before and after the stress period (ΔDDT) express in percent
Time frame: 1 day
Effect of α-tACS on time perception in stressed healthy subjects
time perception refers to how the brain represents the temporal structure of events and of our environment. This ability can be assessed through different experimental designs. In this protocol, the participants will complete a time reproduction task, consisting in tapping at a defined frequency (1Hz) with a push-button. After a training phase (pressing the push-button while being guided), the participant will have to produce the same rhythm on his own. The outcome will be the mean difference between the reference interval (1s) and the time intervals executed by the participant, express in milliseconds
Time frame: 1 day
Plan to share: Undecided
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Started Jan 2024 (actual). Primary completion is estimated for Feb 2027, 36 months after the start.
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