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Completed

NCT Number: NCT02793258

Impact of tDCS on Emotional Processing in Major Depression

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.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression

Acronym: EmoStim

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2016
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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