NCT03224897

Brief Summary

This study aims to investigate the role of the left ventrolateral prefrontal cortex (VLPFC) on cognitive reappraisal, using the reinterpretation strategy. For this purpose, we will produce direct disturbance to the activity of this area through anodal and cathodal transcranial direct current stimulation during a reinterpretation task. A double-blind randomized sham-controlled trial will be conducted. 60 healthy volunteers will be allocated into three groups. Each group will receive one type of stimulation (anodal, cathodal or sham) while accomplishing a cognitive task on reinterpretation using images from the International Affective Pictures System (IAPS). The task consists in applying a given emotional regulation condition (downregulate, upregulate or maintain emotions) to a series of images and ranking the intensity of the emotional arousal felt after doing this procedure to each picture. The effects of tDCS on the subjective evaluation of emotional arousal after reinterpretation in each group will be compared.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 6, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4 months

First QC Date

July 18, 2017

Last Update Submit

May 5, 2020

Conditions

Keywords

ReappraisalEmotion RegulationtDCSReinterpretation

Outcome Measures

Primary Outcomes (1)

  • Subjective Emotional Arousal Rating

    The rating from 1-7 (1=very weak; 7=very strong) of the negative emotional arousal felt by the volunteer after the volunteer after using the reappraisal strategy for each picture.

    20 minutes

Secondary Outcomes (1)

  • Self-evaluation about the success in performing cognitive task

    20 minutes

Other Outcomes (1)

  • ERQ Questionnaire score

    20 minutes

Study Arms (3)

Cathodal tDCS

ACTIVE COMPARATOR
Device: Cathodal tDCS

Anodal tDCS

ACTIVE COMPARATOR
Device: Anodal tDCS

Sham tDCS

SHAM COMPARATOR
Device: Sham tDCS

Interventions

Volunteers will be submitted to 1,0 mA cathodal stimulation during experiment. The stimulation will be applied through a pair of saline-soaked surface sponge electrodes for 20 minutes, with a 10s ramp up and down. The 4,5 x 5,0 cm "active" electrode will be placed over the crossing point between Fz-T3 and F7-Cz and the 12 x 5 cm "return" electrode will be placed over Fp2 according to the 10-20 EEG system.

Cathodal tDCS

1,0mA anodal stimulation will be applied through a pair of saline-soaked surface sponge electrodes for 20 minutes, with a 10s ramp up and down. The 4,5 x 5,0 cm "active" electrode will be placed over the crossing point between Fz-T3 and F7-Cz and the 12 x 5 cm "return" electrode will be placed over Fp2 according to the 10-20 EEG system.

Anodal tDCS
Sham tDCSDEVICE

1,0 mA anodal stimulation will be applied through a pair of saline-soaked surface sponge electrodes for 30 seconds, with a 10s ramp up and down. The 4,5 x 5,0 cm "active" electrode will be placed over the crossing point between Fz-T3 and F7-Cz and the 12 x 5 cm "return" electrode will be placed over Fp2 according to the 10-20 EEG system. The participant will not know when the stimulator is turned off and will continue to perform the experimental task as in the other groups.

Sham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • graduate and post-graduate students at UFPE
  • aged \> 18 years-old

You may not qualify if:

  • seizures antecedent
  • brain tumor
  • neurosurgery antecedent
  • metalic implant on the head
  • cardiac pacemaker
  • current psychotropic usage
  • SRQ-20 score \> 5
  • ASSIST 3.0 (sum from 2-7 questions) \> 10 for alcohol or \> 3 for other drugs
  • left-handed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Applied Neuroscience Laboratory

Recife, Pernambuco, 50740-560, Brazil

Location

Federal University of Pernambucano

Recife, Pernambuco, 50740-560, Brazil

Location

Related Publications (5)

  • Feeser M, Prehn K, Kazzer P, Mungee A, Bajbouj M. Transcranial direct current stimulation enhances cognitive control during emotion regulation. Brain Stimul. 2014 Jan-Feb;7(1):105-12. doi: 10.1016/j.brs.2013.08.006. Epub 2013 Sep 21.

    PMID: 24095257BACKGROUND
  • Ochsner KN, Ray RD, Cooper JC, Robertson ER, Chopra S, Gabrieli JD, Gross JJ. For better or for worse: neural systems supporting the cognitive down- and up-regulation of negative emotion. Neuroimage. 2004 Oct;23(2):483-99. doi: 10.1016/j.neuroimage.2004.06.030.

    PMID: 15488398BACKGROUND
  • Cattaneo Z, Pisoni A, Papagno C. Transcranial direct current stimulation over Broca's region improves phonemic and semantic fluency in healthy individuals. Neuroscience. 2011 Jun 2;183:64-70. doi: 10.1016/j.neuroscience.2011.03.058. Epub 2011 Apr 6.

    PMID: 21477637BACKGROUND
  • Pisoni A, Papagno C, Cattaneo Z. Neural correlates of the semantic interference effect: new evidence from transcranial direct current stimulation. Neuroscience. 2012 Oct 25;223:56-67. doi: 10.1016/j.neuroscience.2012.07.046. Epub 2012 Jul 31.

    PMID: 22863670BACKGROUND
  • Cohen-Maximov T, Avirame K, Floel A, Lavidor M. Modulation of Gestural-verbal Semantic Integration by tDCS. Brain Stimul. 2015 May-Jun;8(3):493-8. doi: 10.1016/j.brs.2014.12.001. Epub 2014 Dec 11.

    PMID: 25558040BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The tDCS device was placed at the back of the participants, so they could not see the parameters of stimulation. The participants of the sham stimulation group received anode stimulation for 30s, and then the device was turned off. The participants feel the initial itching in all conditions, so the are not able to distinguish to which condition of stimulation they are submitted.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: The 60 participants will be divided into 3 groups: anodal, cathodal and sham stimulation. While receiving the transcranial direct current (tDCS) stimulation, participants will perform a reappraisal task. Four series of 15 IAPS pictures will be randomly passed on a computer screen. 3 of the 4 sets of pictures contain negative pictures, matched according to valence and arousal of the IAPS norm ratings (p\<0.05) and were assigned to one of instruction condition (upregulate, downregulate or maintain). The other set will contain neutral pictures with the instruction maintain. Participants will be asked to apply the instruction assigned to each picture and then rank the intensity of negative emotional arousal felt after using the reappraisal strategy, varying from 1 (weak) to 7 (strong). ANOVA will be used to compare the median subjective emotion intensity evaluation for each strategy intra-subjects and inter-groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effects of Transcranial Direct Current Stimulation Over the Left Ventrolateral Prefrontal Cortex on Cognitive Reappraisal

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 21, 2017

Study Start

March 6, 2017

Primary Completion

June 28, 2017

Study Completion

October 31, 2017

Last Updated

May 6, 2020

Record last verified: 2020-05

Locations