Impact of tDCS on Emotional Processing in Major Depression

Major Depressive Disorder Clinical Trial

— EmoStim  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793258
• Other study ID #: 2016-A00415-46
• Status: Completed
• Phase: N/A
• Start date: July 22, 2016
• Est. completion date: December 2021

Study information

• Verified date: January 2022
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
France	Ch Le Vinatier	Lyon	Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Beck depression inventory scale		within 5 days after stimulation
Secondary	Clinical global impression scale		an average of two weeks
Secondary	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
Secondary	Skin conductance measured in speed per microseconds	Recorded with physiologic data system (BIOPAC)	within 5 days after stimulation
Secondary	Heart rate measured in number of heart pulses per milliseconds	Recorded with physiologic data system (BIOPAC)	within 5 days after stimulation
Secondary	Respiratory frequency measured in number of respiratory cycles per minute	Recorded with physiologic data system(BIOPAC)	within 5 days after stimulation

External Links

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