HealthyCONTEST_1NCT03574883
Consciousness Transcranial Alternative Electric STimulation
A study testing tACS and tDCS in people with Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The aim of this study is to investigate the effect of transcranial Alternating Current Stimulation (tACS) at theta frequency and the the effect of transcranial Direct Current Stimulation (tDCS) on the conscious access to visual stimuli. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- tACS and tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2018to 16 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- French social security affiliation
- Absence of neurological and psychiatric disorders
- Absence of antiepileptic treatment
- Normal vision (with or without correction)
- Age between 18 and 60 years
- Right-handedness
- Signed informed consent to participate
Who cannot join
- Person under legal protection (legal guardian, tutor, curator)
- Past medical history of epilepsy
- Past medical history of neurological or psychiatric disorders
- Electrical stimulation contraindication (metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis)
- Antiepileptic and other psychotropes treatment
- Pregnant, parturient or breastfeeding women
- Left-handedness
Trial locations and contacts
1 site in 1 country.
France1 site
Institut du Cerveau et de la Moelle - CR-ICM U 975 / UMRS INSERM 1127
Paris, 75013
About this study
Official title: Effects of the Transcranial Alternative Electric Stimulation on the Consciousness Access in Healthy Subjects
The aim of this study is to investigate the effect of transcranial Alternating Current Stimulation (tACS) at theta frequency and the the effect of transcranial Direct Current Stimulation (tDCS) on the conscious access to visual stimuli. tACS and tDCS are non-invasive stimulation techniques that are used to induce brain oscillations at certain frequency or to increase the brain activity in applied region. Healthy participants will perform a behavioral task measuring conscious access (visual backward metacontrast masking task) before, during and after fronto-parietal tACS or tDCS stimulation which will increase neural activity in the two sites. This will allow us to examine online and remaining effects of the stimulation and the causal role of fronto-parietal activity on conscious access.
Read the detailed description
Behavioral task
The behavioral task consists in presentation of a para-foveal numerical target on a screen for 16 ms either right or left of a central fixation point, followed by a visual mask, made of letters surrounding the target, presented for 250 ms. The delay between the target and the mask (Stimulus Onset Asynchrony - SOA) will be variable (16 ms, 33 ms, 50 ms, 66 ms or 83 ms). Participants will then be asked to perform two tasks. First (objective task), participants will be asked to indicate as quickly as possible whether the target was bigger or smaller than the digit "5". Second (subjective task), they will be requested to judge the visibility of the presented target by indicating whether they had seen the target or not.
tACS
Study design
The study design is composed of three experimental sessions. In these sessions, participants will first complete the behavioral paradigm as presented above while having their brain activity recorded with EEG. Afterwards, they will re-perform the task during and after tACS stimulation. tACS stimulation type will differ in each session : in-phase, anti-phase or sham (see below for further details). Stimulation sessions will occur in a double-blind randomized crossover design (neither the participant nor the experimenter knows which session includes which stimulation type), with at least 2 days of interval between them.
Stimulation
During tACS sessions, 6 Hz stimulation (1000 μA) will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) using an 8-channels stimulator (Starstim NE, Neuroelectrics, Barcelona, Spain) with small round sponge electrodes (25 cm2 surface, maximal current density of 0.06 μA/cm2), controlled via Bluetooth. In the in-phase condition, the phase difference between the two stimulation sites will be 0° which will entrain synchronization between sites. In the anti-phase condition on the other hand, the phase difference will be 180°, which should desynchronize the activity in the two cortices. In the sham condition, the stimulation (also anti-phase) will start with a current intensity of 2000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. Each stimulation session will take 20 minutes and the positions of stimulation electrodes and the duration of the stimulation will be kept identical for all conditions.
tDCS
Study design
The study is composed of two experimental sessions: one tDCS session and one sham session. In the tDCS session, participants will do the behavioral task (with an EEG recording) during and after 20 minutes of 1000 μA tDCS stimulation. As a control, participants will do the behavioral task in a second session (sham session) during which they will have a sham stimulation instead of tDCS stimulation. The two sessions will occur in a double-blind randomized crossover design (neither the participant nor the experimenter knows which session includes which stimulation type), with at least 2 days of interval between them.
Stimulation
During tDCS session, 1000 μA stimulation will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) using an 8-channels stimulator (Starstim NE, Neuroelectrics, Barcelona, Spain) with small round sponge electrodes (25 cm2 surface, maximal current density of 0.06 μA/cm2), controlled via Bluetooth. In the sham condition, the stimulation will start with a current intensity of 1000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. The reason for this subtle manipulation is to make sure that participants will be unable to notice the difference between active tDCS and sham tDCS stimulation. Each stimulation session will take 20 minutes and the positions of stimulation electrodes and the duration of the stimulation will be kept identical for all conditions.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACSDevice
tACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain.
tDCSDevice
tDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain
| Study group | Role | What they receive |
|---|---|---|
| In-phase tACS | Experimental | 6 Hz stimulation (1000 μA) will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) for 20 minutes using an 8-channels stimulator. The phase difference between the two stimulation sites will be 0°. Receives: Device: tACS |
| Anti-phase tACS | Active comparator | 6 Hz stimulation (1000 μA) will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) for 20 minutes using an 8-channels stimulator. The phase difference will be 180°, Receives: Device: tACS |
| Sham tACS | Sham comparator | The stimulation (anti-phase) will start with a current intensity of 1000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. Receives: Device: tACS |
| Active tDCS | Experimental | 1000 μA tDCS stimulation will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) for 20 minutes using an 8-channels stimulator Receives: Device: tDCS |
| Sham tDCS | Sham comparator | The stimulation will start with a current intensity of 1000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in subjective performance on the behavioral task (% of seen masked target) between before and after stimulation.
Change in the percentage of the correct responses on the subjective evaluation, that is the percentage of seen masked target at each SOA over all masked target presented, between before and after stimulation, for each stimulation modality (inphase theta, antiphase theta, sham).
Measured: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.
Secondary outcomes (3)
Change in visual evoked potentials between before and after stimulation.
Change in amplitudes and delays of event related potentials evoked by the target at different SOA and according to the visibility (P1, N1, N2, P300) between before and after stimulation for each stimulation modality.
Measured: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.
Change in quantitative EEG measures between before and after stimulation.
Changes in quantitative EEG measures (spectral power, complexity, connectivity) between before and after stimulation for each stimulation modality.
Measured: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.
Change in objective performance on the behavioral task (% of correct response on the number comparison task for masked target) between before and after stimulation.
Change in the percentage of the correct responses on the objective comparison task, that is the percentage of correct response on the number comparison task for masked target at each SOA, between before and after stimulation, for each stimulation modality (inphase theta, antiphase theta, sham).
Measured: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start23 Apr 2018
- Primary completion16 Jul 2021
- Study completion16 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- This study is composed of two independent sub-studies, one exploring the effects of tACS and the other the effects of tDCS, with different participants assigned to the two sub-studies. There will be 3 arms in tACS group and 2 arms in tDCS group. Among each sub-study, all participants will participate in all arms (hence the cross-over design).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Lionel NACCACHE, MD, PhD, Principal investigator, CR-ICM U 975 /UMRS INSERM 1127Jacobo D SITT, MD, PhD, Principal investigator, CR-ICM U 975 /UMRS INSERM 1127Bertrand HERMANN, MD, Study chair, CR-ICM U 975 /UMRS INSERM 1127
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574883
- Sponsor's protocol ID
- C17-22
- Other IDs
- 2017-A02761-52
- Acronym
- CONTEST_1
- Status last verified
- Mar 2025
- First submitted
- 19 Apr 2018
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Del Cul A, Baillet S, Dehaene S. Brain dynamics underlying the nonlinear threshold for access to consciousness. PLoS Biol. 2007 Oct;5(10):e260. doi: 10.1371/journal.pbio.0050260.
PubMed 17896866Polania R, Nitsche MA, Korman C, Batsikadze G, Paulus W. The importance of timing in segregated theta phase-coupling for cognitive performance. Curr Biol. 2012 Jul 24;22(14):1314-8. doi: 10.1016/j.cub.2012.05.021. Epub 2012 Jun 7.
PubMed 22683259
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Transcranial Alternative Electric Stimulation on the Consciousness Access in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03574883
- Acronym / sponsor ID
- CONTEST_1 / C17-22
- Conditions
- Healthy
- Keywords
- Conscious access, transcranial electric stimulation, tACS, Global neuronal workspace, Masking paradigm, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 16 Jul 2021 (actual)
- Study completion
- 16 Jul 2021 (actual)
- First posted
- 2 Jul 2018 (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.
The aim of this study is to investigate the effect of transcranial Alternating Current Stimulation (tACS) at theta frequency and the the effect of transcranial Direct Current Stimulation (tDCS) on the conscious access to visual stimuli. tACS and tDCS are non-invasive stimulation techniques that are used to induce brain oscillations at certain frequency or to increase the brain activity in applied region. Healthy participants will perform a behavioral task measuring conscious access (visual backward metacontrast masking task) before, during and after fronto-parietal tACS or tDCS stimulation which will increase neural activity in the two sites. This will allow us to examine online and remaining effects of the stimulation and the causal role of fronto-parietal activity on conscious access.
Detailed description
Behavioral task
The behavioral task consists in presentation of a para-foveal numerical target on a screen for 16 ms either right or left of a central fixation point, followed by a visual mask, made of letters surrounding the target, presented for 250 ms. The delay between the target and the mask (Stimulus Onset Asynchrony - SOA) will be variable (16 ms, 33 ms, 50 ms, 66 ms or 83 ms). Participants will then be asked to perform two tasks. First (objective task), participants will be asked to indicate as quickly as possible whether the target was bigger or smaller than the digit "5". Second (subjective task), they will be requested to judge the visibility of the presented target by indicating whether they had seen the target or not.
tACS
Study design
The study design is composed of three experimental sessions. In these sessions, participants will first complete the behavioral paradigm as presented above while having their brain activity recorded with EEG. Afterwards, they will re-perform the task during and after tACS stimulation. tACS stimulation type will differ in each session : in-phase, anti-phase or sham (see below for further details). Stimulation sessions will occur in a double-blind randomized crossover design (neither the participant nor the experimenter knows which session includes which stimulation type), with at least 2 days of interval between them.
Stimulation
During tACS sessions, 6 Hz stimulation (1000 μA) will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) using an 8-channels stimulator (Starstim NE, Neuroelectrics, Barcelona, Spain) with small round sponge electrodes (25 cm2 surface, maximal current density of 0.06 μA/cm2), controlled via Bluetooth. In the in-phase condition, the phase difference between the two stimulation sites will be 0° which will entrain synchronization between sites. In the anti-phase condition on the other hand, the phase difference will be 180°, which should desynchronize the activity in the two cortices. In the sham condition, the stimulation (also anti-phase) will start with a current intensity of 2000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. Each stimulation session will take 20 minutes and the positions of stimulation electrodes and the duration of the stimulation will be kept identical for all conditions.
tDCS
Study design
The study is composed of two experimental sessions: one tDCS session and one sham session. In the tDCS session, participants will do the behavioral task (with an EEG recording) during and after 20 minutes of 1000 μA tDCS stimulation. As a control, participants will do the behavioral task in a second session (sham session) during which they will have a sham stimulation instead of tDCS stimulation. The two sessions will occur in a double-blind randomized crossover design (neither the participant nor the experimenter knows which session includes which stimulation type), with at least 2 days of interval between them.
Stimulation
During tDCS session, 1000 μA stimulation will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) using an 8-channels stimulator (Starstim NE, Neuroelectrics, Barcelona, Spain) with small round sponge electrodes (25 cm2 surface, maximal current density of 0.06 μA/cm2), controlled via Bluetooth. In the sham condition, the stimulation will start with a current intensity of 1000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. The reason for this subtle manipulation is to make sure that participants will be unable to notice the difference between active tDCS and sham tDCS stimulation. Each stimulation session will take 20 minutes and the positions of stimulation electrodes and the duration of the stimulation will be kept identical for all conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
- Model description
- This study is composed of two independent sub-studies, one exploring the effects of tACS and the other the effects of tDCS, with different participants assigned to the two sub-studies. There will be 3 arms in tACS group and 2 arms in tDCS group. Among each sub-study, all participants will participate in all arms (hence the cross-over design).
| Arm | Type | Receives |
|---|---|---|
| In-phase tACS | Experimental | Device: tACS6 Hz stimulation (1000 μA) will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) for 20 minutes using an 8-channels stimulator. The phase difference between the two stimulation sites will be 0°. |
| Anti-phase tACS | Active comparator | Device: tACS6 Hz stimulation (1000 μA) will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) for 20 minutes using an 8-channels stimulator. The phase difference will be 180°, |
| Sham tACS | Sham comparator | Device: tACSThe stimulation (anti-phase) will start with a current intensity of 1000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. |
| Active tDCS | Experimental | Device: tDCS1000 μA tDCS stimulation will be applied simultaneously over the left prefrontal dorso-lateral cortex (F3 of the 10-20 international scalp EEG system) and the left parietal cortex (P3) for 20 minutes using an 8-channels stimulator |
| Sham tDCS | Sham comparator | Device: tDCSThe stimulation will start with a current intensity of 1000 μA lasting for 30 seconds. Afterwards, the intensity will progressively decrease over 20 seconds until cessation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- French social security affiliation
- Absence of neurological and psychiatric disorders
- Absence of antiepileptic treatment
- Normal vision (with or without correction)
- Age between 18 and 60 years
Key exclusion criteria (7 listed)
- Person under legal protection (legal guardian, tutor, curator)
- Past medical history of epilepsy
- Past medical history of neurological or psychiatric disorders
- Electrical stimulation contraindication (metallic intra-cranial implants, pacemaker or implantable cardioverter-defibrillator, cranial prosthesis)
- Antiepileptic and other psychotropes treatment
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 |
|---|---|---|
| tACStACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain. | Device | Anti-phase tACS, In-phase tACS, Sham tACS |
| tDCStDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain | Device | Active tDCS, Sham tDCS |
Primary outcome
Change in subjective performance on the behavioral task (% of seen masked target) between before and after stimulation.
Time frame: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.
Change in the percentage of the correct responses on the subjective evaluation, that is the percentage of seen masked target at each SOA over all masked target presented, between before and after stimulation, for each stimulation modality (inphase theta, antiphase theta, sham).
3 secondary outcomes
Change in visual evoked potentials between before and after stimulation.
Time frame: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.
Change in quantitative EEG measures between before and after stimulation.
Time frame: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.
Change in objective performance on the behavioral task (% of correct response on the number comparison task for masked target) between before and after stimulation.
Time frame: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Background: PubMed 17896866Del Cul A, Baillet S, Dehaene S. Brain dynamics underlying the nonlinear threshold for access to consciousness. PLoS Biol. 2007 Oct;5(10):e260. doi: 10.1371/journal.pbio.0050260.
- Background: PubMed 22683259Polania R, Nitsche MA, Korman C, Batsikadze G, Paulus W. The importance of timing in segregated theta phase-coupling for cognitive performance. Curr Biol. 2012 Jul 24;22(14):1314-8. doi: 10.1016/j.cub.2012.05.021. Epub 2012 Jun 7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lionel NACCACHE, MD, PhD principal investigator
CR-ICM U 975 /UMRS INSERM 1127
Jacobo D SITT, MD, PhD principal investigator
CR-ICM U 975 /UMRS INSERM 1127
Bertrand HERMANN, MD study chair
CR-ICM U 975 /UMRS INSERM 1127
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS and tDCS in people with Healthy, run by Institut National de la Santé Et de la Recherche Médicale, France 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 16 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in subjective performance on the behavioral task (% of seen masked target) between before and after stimulation. (time frame: Measured at each stimulation sessions (three sessions in a randomized cross-over order) for each participant. The three sessions will span in an average of two weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03574883, which also lists 2 linked publications.
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 16 May 2025.