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Impact of tDCS on Emotional Processing in Major Depression (EmoStim)

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ClinicalTrials.gov Identifier: NCT02793258
Recruitment Status : Recruiting
First Posted : June 8, 2016
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Hôpital le Vinatier

Brief Summary:
Background: transcranial direct current stimulation (tDCS) is an innovative treatment for major depression. However, its mechanisms of action are still unclear. Major depression is characterized by impaired processing of emotional information, which returns back to normal after successful antidepressant treatment. In this randomized double-blind study, the investigators aim to assess the effect of tDCS on emotional processing in major depression.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: transcranial direct current stimulation Not Applicable

Detailed Description:

Methods: 40 subjects with major depression (20 active treatment and 20 placebo) will receive ten 30-minutes sessions of active two milliamps or sham tDCS (anode over left dorsolateral prefrontal cortex and cathode over right dorsolateral prefrontal cortex), twice a day for 5 consecutive days. Psychometric assessment of depression (MADRS,Beck Depression Inventory , CGI) and a neuropsychological assessment will be conducted before and after the treatment.

A facial emotion recognition task and an attentional emotional task with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.

The investigators hypothesize that active tDCS will improve emotional processing in major depression, and that this will be observed after 1 and 10 sessions of tDCS.

Conclusions: Studying the impact of transcranial direct current stimulation on emotional processing in major depression could allow to better understand its antidepressant mechanisms


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression
Actual Study Start Date : July 22, 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo tDCS

Subjects will receive 10 30-minutes sessions of sham tDCS, twice a day for 5 consecutive day.

Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.

Device: transcranial direct current stimulation

Subjects will receive 10 30-minutes sessions of two milliamps transcranial direct current stimulation , twice a day for 5 consecutive day.

Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.


Experimental: Active tDCS

receive 10 30-minutes sessions of two milliamps tDCS, twice a day for 5 consecutive day.

Stimulation will be performed using an 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) The twice daily sessions will be separated by at least 2 hours.

Device: transcranial direct current stimulation

Subjects will receive 10 30-minutes sessions of two milliamps transcranial direct current stimulation , twice a day for 5 consecutive day.

Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session.





Primary Outcome Measures :
  1. Number of correct responses at a facial expression recognition task [ Time Frame: within 5 days after stimulation ]

    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



Secondary Outcome Measures :
  1. Evolution of the depressive symptoms measured by MADRS [ Time Frame: an average of two weeks ]
    Montgomery-Asberg Depression Rating Scale is a 10-item scale to evaluate the intensity of the depressive symptoms.

  2. Performance on an attentional dot-probe task [ Time Frame: within 5 days after stimulation ]

    Computerized "dot-probe " attentional task designed for the study. Pairs of emotional faces (neutral/sad ou neutral/happy) are randomly presented on a screen for 1000ms. Then, a probe is presented during 1100ms.subjects are asked to indicate a which side the probe approved 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.


  3. tests of executive functions [ Time Frame: an average of two weeks ]
    Neuropsychological assessment : attentional functioning (TAP), executive functioning (BADS, working memory, go/no-go, stroop), memory (california verbal learning test) Improvement of executive functioning by tDCS will be assessed.

  4. Beck depression inventory scale [ Time Frame: within 5 days after stimulation ]
  5. Clinical global impression scale [ Time Frame: an average of two weeks ]
  6. Eye movements during facial emotion recognition task and attentional task [ Time Frame: within 5 days after stimulation ]
    Recorded by Eye tracker.Measurement of total time spent on specific Region of interest (eyes, nose, mouth, emotional face)

  7. Skin conductance measured in speed per microseconds [ Time Frame: within 5 days after stimulation ]
    Recorded with physiologic data system (BIOPAC)

  8. Heart rate measured in number of heart pulses per milliseconds [ Time Frame: within 5 days after stimulation ]
    Recorded with physiologic data system (BIOPAC)

  9. Respiratory frequency measured in number of respiratory cycles per minute [ Time Frame: within 5 days after stimulation ]
    Recorded with physiologic data system(BIOPAC)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy controls:

  • Age between 18 and 65 years
  • Given consent.

Depressed subjects:

  • Major depressive episode (no psychotic features) according to Diagnostic ans Statistical of Mental Disorders number 5 (DSM 5.0.)
  • Age from 18-65
  • Antidepressant stable for the last 4 weeks
  • MADRS ≥ 20.
  • Given consent

Exclusion Criteria:

Healthy controls:

  • Psychiatric disorder
  • 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)

Depressed subjects:

  • Other psychiatric disorder except for personality disorders
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02793258


Contacts
Contact: HAESEBAERT FREDERIC, PH 0033437914922 frederic.haesebaert@ch-le-vinatier.fr
Contact: GALVAO Filipe, PH 0033437914923 filipe.galvao@ch-le-vinatier.fr

Locations
France
Ch Le Vinatier Recruiting
Lyon, Rhone Alpes, France, 69678
Contact: HAESEBAERT FREDERIC, PH    0033437914922    frederic.haesebaert@ch-le-vinatier.fr   
Contact: GALVAO FILIPE, PH    0033437914923    filipe.galvao@ch-le-viantier.fr   
Sponsors and Collaborators
Hôpital le Vinatier
Investigators
Principal Investigator: HAESEBAERT FREDERIC, PH Centre Hospitalier Le Vinatier

Additional Information:
Responsible Party: Hôpital le Vinatier
ClinicalTrials.gov Identifier: NCT02793258     History of Changes
Other Study ID Numbers: 2016-A00415-46
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hôpital le Vinatier:
tDCS
neuromodulation
depression
cognition

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders