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

Impact of Transcranial Direct Current Stimulation 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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: transcranial direct current stimulation

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhone Alpes
    • Lyon, Rhone Alpes, France, 69678
      • CH Le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of correct responses at 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	within 5 days after stimulation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of the depressive symptoms measured by MADRS	Montgomery-Asberg Depression Rating Scale is a 10-item scale to evaluate the intensity of the depressive symptoms.	an average of two weeks
Performance on an attentional dot-probe task	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.	within 5 days after stimulation
tests of executive functions	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.	an average of two weeks
Beck depression inventory scale		within 5 days after stimulation
Clinical global impression scale		an average of two weeks
Eye movements during facial emotion recognition task and attentional task	Recorded by Eye tracker.Measurement of total time spent on specific Region of interest (eyes, nose, mouth, emotional face)	within 5 days after stimulation
Skin conductance measured in speed per microseconds	Recorded with physiologic data system (BIOPAC)	within 5 days after stimulation
Heart rate measured in number of heart pulses per milliseconds	Recorded with physiologic data system (BIOPAC)	within 5 days after stimulation
Respiratory frequency measured in number of respiratory cycles per minute	Recorded with physiologic data system(BIOPAC)	within 5 days after stimulation

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: HAESEBAERT FREDERIC, PH, Centre Hospitalier Le Vinatier

Publications and helpful links

Helpful Links

• Equip (PSYR2) -Psychiatric Disorders: from Resistance to Response

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2016
• Primary Completion (Actual): May 17, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimate): June 8, 2016

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: tDCS; depression; cognition; neuromodulation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 2016-A00415-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO