HealthyCAF-TASNCT06229002
Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects
A study testing Transcranial alternative current stimulation (tACS) at alpha frequency in people with Healthy, run by Hôpital le Vinatier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Transcranial alternative current stimulation (tACS) at alpha frequency
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2024to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Le Vinatier
Bron, AURA, 69678 CEDEX
POULET EMMANUEL, PUPH, 0033437915120 ext. +33, emmanuel.poulet@chu-lyon.fr
SARTELET Lydie, 0033437915531, lydie.sartelet@ch-le-vinatier.fr
About this study
Official title: Biological, Neuropsychological and Electrophysiological Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects
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
Read the 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.
- Conditions
- Healthy
- Being tested
- Transcranial alternative current stimulation (tACS) at alpha frequency, Sham stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial alternative current stimulation (tACS) at alpha frequencyProcedure or surgery
Single session of tACS
Sham stimulationProcedure or surgery
Single session of tACS sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Transcranial alternative current stimulation (tACS) at alpha frequency |
| 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) Receives: Procedure: Sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (13)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start24 Jan 2024
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo-controlled, randomized parallel arms study including 40 healthy participants who will receive active and placebo α-tACS
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229002
- Sponsor's protocol ID
- 2023-A01368-37
- Acronym
- CAF-TAS
- Status last verified
- Dec 2023
- First submitted
- 20 Dec 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological, Neuropsychological and Electrophysiological Effect of Transcranial Alternative Current Stimulation at Alpha Frequency (α-tACS) on Stressed Healthy Subjects
- ClinicalTrials.gov ID
- NCT06229002
- Acronym / sponsor ID
- CAF-TAS / 2023-A01368-37
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, randomized parallel arms study including 40 healthy participants who will receive active and placebo α-tACS
| Arm | Type | Receives |
|---|---|---|
| Active tACS stimulation | Experimental | Procedure: Transcranial alternative current stimulation (tACS) at alpha frequencyTranscranial 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) |
| Sham stimulation | Placebo comparator | Procedure: Sham stimulationSingle 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) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial alternative current stimulation (tACS) at alpha frequencySingle session of tACS | Procedure or surgery | Active tACS stimulation |
| Sham stimulationSingle session of tACS sham stimulation | Procedure or surgery | Sham stimulation |
Primary outcome
Area under the curve (AUC) of the cortisol secretion after the stress task.
Time frame: 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.
13 secondary outcomes
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
Effect of α-tACS on time perception in stressed healthy subjects
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternative current stimulation (tACS) at alpha frequency in people with Healthy, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve (AUC) of the cortisol secretion after the stress task. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.