<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03286075</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A01258-43</org_study_id>
    <nct_id>NCT03286075</nct_id>
  </id_info>
  <brief_title>Impact of tDCS on Emotional Processing in Healthy Subjects.</brief_title>
  <acronym>EmoStimH</acronym>
  <official_title>Impact of Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex on Emotional Processing in Healthy Subjects.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital le Vinatier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital le Vinatier</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and&#xD;
      regulation.&#xD;
&#xD;
      Emotions continually influence other cognitive functions such as attentional resources&#xD;
      .Emotions also influence a subject's automatic physiological responses .&#xD;
&#xD;
      Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment,&#xD;
      often used in major depression.&#xD;
&#xD;
      Various studies have shown that it is possible to modulate emotional processing in healthy&#xD;
      subjects, however the impact of this modulation on attentional resources and physiological&#xD;
      responses has not been studied. Also, the mechanisms of action of the tDCS on emotional&#xD;
      processing are still unclear.&#xD;
&#xD;
      It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better&#xD;
      understand the network and mechanisms at stake in the processes.&#xD;
&#xD;
      Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS&#xD;
      (anode, cathode and placebo) on the processing of emotions and the impact on attentional&#xD;
      resources, and physiological responses.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on&#xD;
      the processing of emotions and the impact on attentional resources, and physiological&#xD;
      responses, subjects will undertake 3 tasks before and after a unique tDCS session of 30&#xD;
      minutes.&#xD;
&#xD;
      The first task is a facial expression recognition task, the second measures the attentional&#xD;
      processing of emotional information (&quot;Free-viewing task&quot;) and the last task focuses on&#xD;
      working memory (digit sorting task).&#xD;
&#xD;
      Each task has its cognitive variables but physiological responses will also be measured&#xD;
      during each task before and after the tDCS session (Eye movement, i.e. Pupil dilatation and&#xD;
      time spent on region of interest; heart rate, skin conductance and respiratory frequency).&#xD;
&#xD;
      3 arms will take part in the study: Anode tDCS Cathode tDCS Placebo tDCS These 3 types of&#xD;
      tDCS stimulation will enable us to study the different modulations possible for the DLPFC and&#xD;
      the impact on all the variables previously mentioned.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The department in charge of this research is no longer able to follow this project. Only two&#xD;
    inclusions this study is close&#xD;
  </why_stopped>
  <start_date type="Actual">July 16, 2018</start_date>
  <completion_date type="Actual">February 12, 2019</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance on a facial expression recognition task</measure>
    <time_frame>Change from baseline on a facial expression recognition task at one day</time_frame>
    <description>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.&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Performance on a task measuring the attentional processing of emotional information</measure>
    <time_frame>baseline</time_frame>
    <description>Computerized &quot;free viewing&quot; 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.&#xD;
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.&#xD;
Skin conductance, respiratory and heart rate frequency are also recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance on a task measuring working memory</measure>
    <time_frame>baseline</time_frame>
    <description>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.&#xD;
During this task, pupil dilatation is recorded by an eye-tracking device. Skin conductance, respiratory and heart rate frequency are also recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Eye movements during facial emotion recognition task, attentional task and working memory task</measure>
    <time_frame>baseline</time_frame>
    <description>total time spent on Region of Interest (for the emotional tasks) and pupil dilatation will be recorded by an SMI RED 250 Eye tracker.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin conductance during facial emotion recognition task, attentional task and working memory task</measure>
    <time_frame>baseline</time_frame>
    <description>this measure will be recorded with a BIOPAC system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart Rate during facial emotion recognition task, attentional task and working memory task</measure>
    <time_frame>baseline</time_frame>
    <description>this measure will be recorded with a BIOPAC system.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory frequency during facial emotion recognition task, attentional task and working memory task</measure>
    <time_frame>baseline</time_frame>
    <description>this measure will be recorded with a BIOPAC system.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Transcranial Direct Current Stimulation</condition>
  <arm_group>
    <arm_group_label>Anode tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects in this arm will undertake a unique session of tDCS on the DLPFC (anode on the left DLPF).&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cathode tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects in this arm will undertake a unique session of tDCS on the DLPFC (cathode on the left DLPF).&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo tDCS</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The subjects in this arm will undertake a unique session of tDCS on the DLPFC (placebo).&#xD;
Subjects will receive a 30-minutes SHAM session of tDCS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS Anode session</intervention_name>
    <description>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.&#xD;
The arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes.&#xD;
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).</description>
    <arm_group_label>Anode tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS Cathode session</intervention_name>
    <description>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.&#xD;
This arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes.&#xD;
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).</description>
    <arm_group_label>Cathode tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>tDCS Placebo session</intervention_name>
    <description>This arm will help compare the effects of stimulation versus no stimulation on emotional processing, attentional resources and physiological responses.&#xD;
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)</description>
    <arm_group_label>Placebo tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men and women aged between 18 and 65 years&#xD;
&#xD;
          -  Written given consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric disorder&#xD;
&#xD;
          -  Refusal from the subject&#xD;
&#xD;
          -  Addiction except for tobacco addiction&#xD;
&#xD;
          -  Ocular disease (except from refraction disorders), neurologic or cardiac disease.&#xD;
&#xD;
          -  Neuroleptic or anticonvulsivant treatment&#xD;
&#xD;
          -  presence of a specific contraindication for tDCS (e.g., personal history of epilepsy,&#xD;
             metallic head implant, cardiac pacemaker)&#xD;
&#xD;
          -  pregnant or breastfeeding women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HAESEBAERT FREDERIC, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vinatier Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ch Le Vinatier</name>
      <address>
        <city>Lyon</city>
        <state>Rhone Alpes</state>
        <zip>69678</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <last_update_submitted>October 1, 2020</last_update_submitted>
  <last_update_submitted_qc>October 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>DLPFC, tDCS, emotional processing</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03286075
org study id: 2016-A01258-43
nct id: NCT03286075
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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
primary purpose: Health Services Research
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Performance on a facial expression recognition task
time frame: Change from baseline on a facial expression recognition task at one day
description: 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.
measure: Performance on a task measuring the attentional processing of emotional information
time frame: baseline
description: 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.
measure: Performance on a task measuring working memory
time frame: baseline
description: 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.
measure: Eye movements during facial emotion recognition task, attentional task and working memory task
time frame: baseline
description: total time spent on Region of Interest (for the emotional tasks) and pupil dilatation will be recorded by an SMI RED 250 Eye tracker.
measure: Skin conductance during facial emotion recognition task, attentional task and working memory task
time frame: baseline
description: this measure will be recorded with a BIOPAC system.
measure: Heart Rate during facial emotion recognition task, attentional task and working memory task
time frame: baseline
description: this measure will be recorded with a BIOPAC system.
measure: Respiratory frequency during facial emotion recognition task, attentional task and working memory task
time frame: baseline
description: this measure will be recorded with a BIOPAC system.
arm group label: Anode tDCS
arm group type: Experimental
description: 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.
arm group label: Cathode tDCS
arm group type: Experimental
description: 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.
arm group label: Placebo tDCS
arm group type: Placebo Comparator
description: 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.
intervention type: Device
intervention name: tDCS Anode session
description: 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).
arm group label: Anode tDCS
intervention type: Device
intervention name: tDCS Cathode session
description: 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).
arm group label: Cathode tDCS
intervention type: Device
intervention name: tDCS Placebo session
description: 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)
arm group label: Placebo tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: HAESEBAERT FREDERIC, PH
role: Principal Investigator
affiliation: Vinatier Hospital
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No