Impact of tDCS on Emotional Processing in Healthy Subjects.

NCT03286075 | Terminated DMC

• 1 other identifier: 2016-A01258-43
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The dorsolateral prefrontal cortex (DLPFC) plays a key part in emotional processing and regulation. Emotions continually influence other cognitive functions such as attentional resources .Emotions also influence a subject's automatic physiological responses . Transcranial direct current stimulation (tDCS) is an innovative neuro-modulation treatment, often used in major depression. Various studies have shown that it is possible to modulate emotional processing in healthy subjects, however the impact of this modulation on attentional resources and physiological responses has not been studied. Also, the mechanisms of action of the tDCS on emotional processing are still unclear. It is necessary to explore the modulation of the DLPFC in healthy subjects in order to better understand the network and mechanisms at stake in the processes. Thus, investigators plan to study the modulation of the DLPFC (left and right) by tDCS (anode, cathode and placebo) on the processing of emotions and the impact on attentional resources, and physiological responses.

Conditions

Transcranial Direct Current Stimulation

Keywords

DLPFC, tDCS, emotional processing

Outcome Measures

Primary Outcomes (1)

• Performance on 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.

  Change from baseline on a facial expression recognition task at one day

Secondary Outcomes (6)

• Performance on a task measuring the attentional processing of emotional information

  baseline

• Performance on a task measuring working memory

  baseline

• Eye movements during facial emotion recognition task, attentional task and working memory task

  baseline

• Skin conductance during facial emotion recognition task, attentional task and working memory task

  baseline

• Heart Rate during facial emotion recognition task, attentional task and working memory task

  baseline

Study Arms (3)

Anode tDCS

EXPERIMENTAL

The subjects in this arm will undertake a unique session of tDCS on the DLPFC (anode on the left DLPF). Subjects will receive a 30-minutes session of 2mA tDCS. Facial emotion recognition task and attentional and working memory tasks with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the session.

Device: tDCS Anode session

Cathode tDCS

EXPERIMENTAL

The subjects in this arm will undertake a unique session of tDCS on the DLPFC (cathode on the left DLPF). Subjects will receive a 30-minutes session of 2mA tDCS. Facial emotion recognition task and attentional and working memory tasks with measurement of eye-tracking, heart rate, respiratory frequency and skin conductance will be conducted before and after the session.

Device: tDCS Cathode session

Placebo tDCS

PLACEBO COMPARATOR

The subjects in this arm will undertake a unique session of tDCS on the DLPFC (placebo). Subjects will receive a 30-minutes SHAM session of tDCS.

Device: tDCS Placebo session

Interventions

tDCS Anode session DEVICE

The aim of this unique anode tDCS session is to study the possibility of enhancing emotional processing, attentional resources and physiological responses in healthy subjects. The arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes. Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric 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).

Anode tDCS

tDCS Cathode session DEVICE

The aim of this unique cathode tDCS session is to study the possibility of inhibiting or altering emotional processing, attentional resources and physiological responses in healthy subjects. This arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes. Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Cathode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and anode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system).

Cathode tDCS

tDCS Placebo session DEVICE

This arm will help compare the effects of stimulation versus no stimulation on emotional processing, attentional resources and physiological responses. Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric 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)

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:

• Men and women aged between 18 and 65 years
• Written given consent

You may not qualify if:

• Psychiatric disorder
• Refusal from the subject
• 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)
• pregnant or breastfeeding women

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

Study Officials

• HAESEBAERT FREDERIC, PH

  Vinatier Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 3 arms will take part in the study: Anode tDCS Cathode tDCS Placebo tDCS These 3 types of tDCS stimulation will enable us to study the different modulations possible for the DLPFC and the impact on all the variables previously mentioned

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 18, 2017
• Study Start: July 16, 2018
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: October 5, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)