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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
transcranial direct current stimulation
Sponsored by
Hôpital le Vinatier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring tDCS, neuromodulation, depression, cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Ch Le Vinatier

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo tDCS

Active tDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Beck depression inventory scale
Clinical global impression scale
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)
Skin conductance measured in speed per microseconds
Recorded with physiologic data system (BIOPAC)
Heart rate measured in number of heart pulses per milliseconds
Recorded with physiologic data system (BIOPAC)
Respiratory frequency measured in number of respiratory cycles per minute
Recorded with physiologic data system(BIOPAC)

Full Information

First Posted
May 18, 2016
Last Updated
January 26, 2022
Sponsor
Hôpital le Vinatier
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1. Study Identification

Unique Protocol Identification Number
NCT02793258
Brief Title
Impact of tDCS on Emotional Processing in Major Depression
Acronym
EmoStim
Official Title
Impact of Transcranial Direct Current Stimulation on Emotional Processing in Major Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2016 (Actual)
Primary Completion Date
May 17, 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
tDCS, neuromodulation, depression, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HAESEBAERT FREDERIC, PH
Organizational Affiliation
Centre Hospitalier le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Le Vinatier
City
Lyon
State/Province
Rhone Alpes
ZIP/Postal Code
69678
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.ch-le-vinatier.fr/offre-de-soins/la-recherche/les-equipes/equipe-psr2-706.html
Description
Equip (PSYR2) -Psychiatric Disorders: from Resistance to Response

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Impact of tDCS on Emotional Processing in Major Depression

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