Impact of tDCS on Emotional Processing in Major Depression

NCT02793258 | Completed DMC

• 1 other identifier: 2016-A00415-46
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

tDCS; neuromodulation; depression; cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Evolution of the depressive symptoms measured by MADRS

  an average of two weeks

• Performance on an attentional dot-probe task

  within 5 days after stimulation

• tests of executive functions

  an average of two weeks

• Beck depression inventory scale

  within 5 days after stimulation

• Clinical global impression scale

  an average of two weeks

Study Arms (2)

Placebo tDCS

PLACEBO COMPARATOR

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

Active tDCS

EXPERIMENTAL

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

Interventions

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.

Active tDCS; Placebo tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

Related Links

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

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• HAESEBAERT FREDERIC, PH

  Centre Hospitalier le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: June 8, 2016
• Study Start: July 22, 2016
• Primary Completion: May 17, 2021
• Study Completion: December 1, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)