Impact of tDCS on Emotional Processing in Major Depression

NCT ID: NCT02793258

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-22
• Study Completion Date: 2021-12-31

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

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

transcranial direct current stimulation

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HAESEBAERT FREDERIC, PH

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier le Vinatier

Locations

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, France

Countries

France

Related Links

http://www.ch-le-vinatier.fr/offre-de-soins/la-recherche/les-equipes/equipe-psr2-706.html

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

Other Identifiers

2016-A00415-46

Identifier Type: -

Identifier Source: org_study_id