Transcranial Direct Current StimulationEmoStimHNCT03286075
Impact of tDCS on Emotional Processing in Healthy Subjects.
A study testing tDCS Anode session and tDCS Cathode session in people with Transcranial Direct Current Stimulation, run by Hôpital le Vinatier at 1 site in France.
Trial summary
The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and regulation. Emotions continually influence other cognitive functions such as attentional resources .Emotions also influence a subject's automatic physiological responses . Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Transcranial Direct Current Stimulation
- What is being tested?
- tDCS Anode session and tDCS Cathode session
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2018to 12 Feb 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 65 years
- Written given consent
Who cannot join
- Psychiatric disorder
- Refusal from the subject
- Addiction except for tobacco addiction
- Ocular disease (except from refraction disorders), neurologic or cardiac disease.
- Neuroleptic or anticonvulsivant treatment
- presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
- pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex on Emotional Processing in Healthy Subjects.
The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and regulation.
Emotions continually influence other cognitive functions such as attentional resources .Emotions also influence a subject's automatic physiological responses .
Read more
Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment, often used in major depression.
Various studies have shown that it is possible to modulate emotional processing in healthy subjects, however the impact of this modulation on attentional resources and physiological responses has not been studied. Also, the mechanisms of action of the tDCS on emotional processing are still unclear.
It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better understand the network and mechanisms at stake in the processes.
Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses.
Read the detailed description
To study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses, subjects will undertake 3 tasks before and after a unique tDCS session of 30 minutes.
The first task is a facial expression recognition task, the second measures the attentional processing of emotional information ("Free-viewing task") and the last task focuses on working memory (digit sorting task).
Each task has its cognitive variables but physiological responses will also be measured during each task before and after the tDCS session (Eye movement, i.e. Pupil dilatation and time spent on region of interest; heart rate, skin conductance and respiratory frequency).
3 arms will take part in the study: Anode tDCS Cathode tDCS Placebo tDCS These 3 types of tDCS stimulation will enable us to study the different modulations possible for the DLPFC and the impact on all the variables previously mentioned.
- Conditions
- Transcranial Direct Current Stimulation
- Being tested
- tDCS Anode session, tDCS Cathode session, tDCS Placebo session
- Keywords
- DLPFC, tDCS, emotional processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCS Anode sessionDevice
The aim of this unique anode tDCS session is to study the possibility of enhancing emotional processing, attentional resources and physiological responses in healthy subjects.
The arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes.
Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system).
tDCS Cathode sessionDevice
The aim of this unique cathode tDCS session is to study the possibility of inhibiting or altering emotional processing, attentional resources and physiological responses in healthy subjects.
This arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes.
Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Cathode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and anode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system).
tDCS Placebo sessionDevice
This arm will help compare the effects of stimulation versus no stimulation on emotional processing, attentional resources and physiological responses.
Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system)
| Study group | Role | What they receive |
|---|---|---|
| Anode tDCS | Experimental | The subjects in this arm will undertake a unique session of tDCS on the DLPFC (anode on the left DLPF).
Subjects will receive a 30-minutes session of 2mA tDCS. Facial emotion recognition task and attentional and working memory tasks with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the session. Receives: Device: tDCS Anode session |
| Cathode tDCS | Experimental | The subjects in this arm will undertake a unique session of tDCS on the DLPFC (cathode on the left DLPF).
Subjects will receive a 30-minutes session of 2mA tDCS. Facial emotion recognition task and attentional and working memory tasks with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the session. Receives: Device: tDCS Cathode session |
| Placebo tDCS | Placebo comparator | The subjects in this arm will undertake a unique session of tDCS on the DLPFC (placebo).
Subjects will receive a 30-minutes SHAM session of tDCS. Receives: Device: tDCS Placebo session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on a facial expression recognition task
A computerized facial expression recognition task was designed for the study. 240 pictures of emotional faces (8 identities, expressing anger, sadness, happiness, surprise, disgust, or fear, morphed with intensity of 20, 40, 50, 60 and 80%) are randomly displayed on a screen for 500ms. Subjects are asked to identify the emotion by answering on a keyboard.
Rate of correct responses is the main outcome. During this task, eye movements are recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded.
Measured: Change from baseline on a facial expression recognition task at one day
Secondary outcomes (6)
Performance on a task measuring the attentional processing of emotional information
Computerized "free viewing" attentional task designed for the study. Pairs of emotional faces (neutral/sad ou neutral/happy) are randomly presented on a screen for 3500ms. Subjects are asked to freely explore the faces.
During this task, eye movements are recorded by an eye-tracking device. Total time spent on Region of Interest (sad, happy or neutral face) is measured.
Skin conductance, respiratory and heart rate frequency are also recorded.
Measured: baseline
Performance on a task measuring working memory
This working memory task is computerized and designed for this study. It is a digit sorting task in which 5 digits will appear on the screen. After that subjects will mentally have to put the digits in the right order. Subjects will then see a target digit and have to assess whether this target digit is the same as the middle digit in the series previously sorted.
During this task, pupil dilatation is recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded.
Measured: baseline
Eye movements during facial emotion recognition task, attentional task and working memory task
total time spent on Region of Interest (for the emotional tasks) and pupil dilatation will be recorded by an SMI RED 250 Eye tracker.
Measured: baseline
Skin conductance during facial emotion recognition task, attentional task and working memory task
this measure will be recorded with a BIOPAC system.
Measured: baseline
Heart Rate during facial emotion recognition task, attentional task and working memory task
this measure will be recorded with a BIOPAC system.
Measured: baseline
Respiratory frequency during facial emotion recognition task, attentional task and working memory task
this measure will be recorded with a BIOPAC system.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start16 Jul 2018
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
Why it stopped: The department in charge of this research is no longer able to follow this project. Only two inclusions this study is close
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Direct Current StimulationStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arms will take part in the study: Anode tDCS Cathode tDCS Placebo tDCS These 3 types of tDCS stimulation will enable us to study the different modulations possible for the DLPFC and the impact on all the variables previously mentioned
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HAESEBAERT FREDERIC, PH, Principal investigator, Vinatier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286075
- Sponsor's protocol ID
- 2016-A01258-43
- Acronym
- EmoStimH
- Status last verified
- Sep 2020
- First submitted
- 12 Sep 2017
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex on Emotional Processing in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT03286075
- Acronym / sponsor ID
- EmoStimH / 2016-A01258-43
- Conditions
- Transcranial Direct Current Stimulation
- Keywords
- DLPFC, tDCS, emotional processing
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The department in charge of this research is no longer able to follow this project. Only two inclusions this study is close
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 18 Sep 2017 (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 dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and regulation.
Emotions continually influence other cognitive functions such as attentional resources .Emotions also influence a subject's automatic physiological responses .
Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment, often used in major depression.
Various studies have shown that it is possible to modulate emotional processing in healthy subjects, however the impact of this modulation on attentional resources and physiological responses has not been studied. Also, the mechanisms of action of the tDCS on emotional processing are still unclear.
It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better understand the network and mechanisms at stake in the processes.
Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses.
Detailed description
To study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses, subjects will undertake 3 tasks before and after a unique tDCS session of 30 minutes.
The first task is a facial expression recognition task, the second measures the attentional processing of emotional information ("Free-viewing task") and the last task focuses on working memory (digit sorting task).
Each task has its cognitive variables but physiological responses will also be measured during each task before and after the tDCS session (Eye movement, i.e. Pupil dilatation and time spent on region of interest; heart rate, skin conductance and respiratory frequency).
3 arms will take part in the study: Anode tDCS Cathode tDCS Placebo tDCS These 3 types of tDCS stimulation will enable us to study the different modulations possible for the DLPFC and the impact on all the variables previously mentioned.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 arms will take part in the study: Anode tDCS Cathode tDCS Placebo tDCS These 3 types of tDCS stimulation will enable us to study the different modulations possible for the DLPFC and the impact on all the variables previously mentioned
| Arm | Type | Receives |
|---|---|---|
| Anode tDCS | Experimental | Device: tDCS Anode sessionThe subjects in this arm will undertake a unique session of tDCS on the DLPFC (anode on the left DLPF). Subjects will receive a 30-minutes session of 2mA tDCS. Facial emotion recognition task and attentional and working memory tasks with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the session. |
| Cathode tDCS | Experimental | Device: tDCS Cathode sessionThe subjects in this arm will undertake a unique session of tDCS on the DLPFC (cathode on the left DLPF). Subjects will receive a 30-minutes session of 2mA tDCS. Facial emotion recognition task and attentional and working memory tasks with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the session. |
| Placebo tDCS | Placebo comparator | Device: tDCS Placebo sessionThe subjects in this arm will undertake a unique session of tDCS on the DLPFC (placebo). Subjects will receive a 30-minutes SHAM session of tDCS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged between 18 and 65 years
- Written given consent
Key exclusion criteria (7 listed)
- Psychiatric disorder
- Refusal from the subject
- Addiction except for tobacco addiction
- Ocular disease (except from refraction disorders), neurologic or cardiac disease.
- Neuroleptic or anticonvulsivant 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 |
|---|---|---|
| tDCS Anode sessionThe aim of this unique anode tDCS session is to study the possibility of enhancing emotional processing, attentional resources and physiological responses in healthy subjects. The arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes. Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system). | Device | Anode tDCS |
| tDCS Cathode sessionThe aim of this unique cathode tDCS session is to study the possibility of inhibiting or altering emotional processing, attentional resources and physiological responses in healthy subjects. This arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes. Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Cathode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and anode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system). | Device | Cathode tDCS |
| tDCS Placebo sessionThis arm will help compare the effects of stimulation versus no stimulation on emotional processing, attentional resources and physiological responses. Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system) | Device | Placebo tDCS |
Primary outcome
Performance on a facial expression recognition task
Time frame: Change from baseline on a facial expression recognition task at one day
A computerized facial expression recognition task was designed for the study. 240 pictures of emotional faces (8 identities, expressing anger, sadness, happiness, surprise, disgust, or fear, morphed with intensity of 20, 40, 50, 60 and 80%) are randomly displayed on a screen for 500ms. Subjects are asked to identify the emotion by answering on a keyboard. Rate of correct responses is the main outcome. During this task, eye movements are recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded.
6 secondary outcomes
Performance on a task measuring the attentional processing of emotional information
Time frame: baseline
Performance on a task measuring working memory
Time frame: baseline
Eye movements during facial emotion recognition task, attentional task and working memory task
Time frame: baseline
Skin conductance during facial emotion recognition task, attentional task and working memory task
Time frame: baseline
Heart Rate during facial emotion recognition task, attentional task and working memory task
Time frame: baseline
Respiratory frequency during facial emotion recognition task, attentional task and working memory task
Time frame: baseline
Results and safety
The study was stopped early (reason given: The department in charge of this research is no longer able to follow this project. Only two inclusions this study is close). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2020.
- 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.
HAESEBAERT FREDERIC, PH principal investigator
Vinatier Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS Anode session and tDCS Cathode session in people with Transcranial Direct Current Stimulation, 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 2 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: stopped early, as of the sponsor's last update on 5 Oct 2020. 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 was stopped early (reason given: The department in charge of this research is no longer able to follow this project. Only two inclusions this study is close). Results are not available in the source record.
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?
Performance on a facial expression recognition task (time frame: Change from baseline on a facial expression recognition task at one 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 5 Oct 2020.