Impact of tDCS on Emotional Processing in Healthy Subjects.

NCT ID: NCT03286075

Last Updated: 2020-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-16

Study Completion Date

2019-02-12

Brief Summary

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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.

Detailed Description

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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, subjects will undertake 3 tasks before and after a unique tDCS session of 30 minutes.

The first task is a facial expression recognition task, the second measures the attentional processing of emotional information ("Free-viewing task") and the last task focuses on working memory (digit sorting task).

Each task has its cognitive variables but physiological responses will also be measured during each task before and after the tDCS session (Eye movement, i.e. Pupil dilatation and time spent on region of interest; heart rate, skin conductance and respiratory frequency).

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.

Conditions

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Transcranial Direct Current Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Anode tDCS

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.

Group Type EXPERIMENTAL

tDCS Anode session

Intervention Type 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).

Cathode tDCS

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.

Group Type EXPERIMENTAL

tDCS Cathode session

Intervention Type 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).

Placebo tDCS

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.

Group Type PLACEBO_COMPARATOR

tDCS Placebo session

Intervention Type 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)

Interventions

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tDCS Anode session

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).

Intervention Type DEVICE

tDCS Cathode session

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).

Intervention Type DEVICE

tDCS Placebo session

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)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hôpital le Vinatier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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HAESEBAERT FREDERIC, PH

Role: PRINCIPAL_INVESTIGATOR

Vinatier Hospital

Locations

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Ch Le Vinatier

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Countries

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France

Other Identifiers

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2016-A01258-43

Identifier Type: -

Identifier Source: org_study_id

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