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Emotion RecognitionNCT05623072

The Effect of tDCS on Emotion Recognition and EEG

A study testing Active tDCS in people with Emotion Recognition, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Purpose and Importance of the Project: Emotion recognition, which is defined as the process of interpreting an individual's emotional state by looking at their facial expressions, is important in maintaining social relations and communication in a healthy way. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Emotion Recognition
What is being tested?
Active tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2022to 15 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Being between the ages of 18-40,
  • Having a score of 17 or less on the Beck Depression Inventory

Who cannot join

  • Having a history of serious neurological and psychiatric illness,
  • Currently taking medication that alters the cortical excitability level,
  • Having visual defects that cannot be corrected with glasses,
  • Left hand dominant,
  • Use of intracranial metal objects, implanted stimulating devices or pacemakers

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul Medipol University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of tDCS on Emotion Recognition and EEG Oscillations in Healthy Adults

Purpose and Importance of the Project: Emotion recognition, which is defined as the process of interpreting an individual's emotional state by looking at their facial expressions, is important in maintaining social relations and communication in a healthy way. Difficulties in emotion recognition can be seen in various neurodevelopmental or psychiatric disorders. The ventromedial prefrontal cortex (vmPFC) is one of the regions that is important in the function of emotion recognition from facial expressions. Transcranial Direct Current Stimulation (tDCS) is a non-invasive, painless method of brain stimulation that provides either excitatory or inhibitory effects on different parts of the brain. When the literature is examined, it is seen that studies on the effectiveness of tDCS on emotion recognition are limited and stimulation is generally applied to the right or left dorsolateral prefrontal cortex areas in these studies. On the other hand, no study has been found examining the effect of stimulation of the ventromedial prefrontal cortex on emotion recognition. In this study, it is aimed to investigate the effect of anodal stimulation of the ventromedial prefrontal cortex, which is significantly related to emotion recognition skills, on emotion recognition and EEG oscillations.

Methods: It is an experimental, randomised controlled trial. The data will be collected with the convenience sampling method from healthy and volunteer participants. The matched-group design method will be used. As a result of the power analysis, it was determined that the current study should be done with at least 34 participants. In the study, it is aimed to include a total of 60 participants in the experimental (tDCS) and control (sham) groups. Measurement instruments are "Informed Voluntary Consent Form"; "Demographic Information Form"; "Edinburgh Hand Preference Survey"; "Beck Depression Scale"; "Amsterdam Dynamic Facial Expression Set - Bath Intensity Variations (ADFES-BIV)"; "Mind-Reading Test"; EEG and tDCS devices. Participants will be subjected to the emotion recognition task before and after the tDCS. In addition, resting state EEG recordings will be taken before and after the tDCS from 34 participants.

Read the detailed description

Measurement instruments:

  • Informed Voluntary Consent Form
  • Demographic Information Form
  • Edinburgh Hand Preference Survey
  • Beck Depression Scale
  • Amsterdam Dynamic Facial Expression Set - Bath Intensity Variations (ADFES-BIV)
  • Reading the Mind in the Eyes Test
  • EEG and tDCS devices

Statistics:

The findings obtained from experimental and control groups the pretest-posttest of the emotion recognition and resting state EEG measurement will be evaluated with Repeated Measures Analysis of Variance (within and between groups) (or Friedman Analysis, which is its non-parametric counterpart). For all tests applied to the variables, the significance value will be accepted as p<0.05.

Being tested
Active tDCS, Sham tDCS
Keywords
Emotion Recognition, tDCS, EEG Oscillations, vmPFC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active tDCSDevice

    20 min, 2 milliampere (mA), Anodal tDCS in vmPFC

  • Sham tDCSDevice

    20 min, vmPFC Sham tDCS

Study groups in NCT05623072
Study groupRoleWhat they receive
Experimental groupActive comparatorParticipants will take active tDCS stimulation
Receives: Device: Active tDCS
Control groupSham comparatorParticipants will take sham tDCS stimulation
Receives: Device: Sham tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in EEG Oscillations for active vs. sham stimulation

    The EEG oscillations recording is to measure resting-state brain oscillations from pre and post measurements. There are the five frequencies band which are Delta (0.5-3,5 Hz), Theta (4-7 Hz), Alpha (8-13 Hz), Beta (15-30 Hz) and Gamma (30-100 Hz). Data will be record simultaneously and analyzed. The analysis will be done with the BrainVisionAnalyzer program and power analysis will be made in Delta, Theta, Alpha, Beta, Gamma bands and the averages will be compared. Oscillations will be evaluated in terms of averages changing as an indicator of the effect of the neuromodulation preceding it.

    Measured: Baseline, 5 minutes after completion of the active/sham stimulation

  2. Change in Emotion Recognition Task score for active vs. sham stimulation

    The task used to measure emotion recognition skills from pre and post test score.

    -Amsterdam Dynamic Facial Expression Set - Bath Intensity Variations (ADFES-BIV) is a standard set of video stimuli of emotional expressions. Task results are changing between 0-81 points. Score averages will compare between pre and post test. Data will be record Excel by Psychopy program simultaneously. Performance will be evaluated for accuracy as an indicator of the effect of the neuromodulation preceding it.

    Measured: Baseline, 20 minutes after completion of the active/sham stimulation

  3. Change in Reading the Mind in the Eyes Test

    -Reading the Mind in the Eyes Test is a task that asked to mark the option that best describes what the person in the picture is thinking or feeling. Task results are changing between 0-32 points. Score averages will compare between pre and post test. Performance will be evaluated for accuracy as an indicator of the effect of the neuromodulation preceding it.

    Measured: Baseline, 20 minutes after completion of the active/sham stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start15 Dec 2022
  3. Primary completion15 Apr 2023
  4. Study completion15 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
It is an experimental, randomised controlled trial. The data will be collected with the convenience sampling method from healthy and volunteer participants. The matched-group design method will be used.
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623072
Sponsor's protocol ID
E-10840098-772.02-2695
Status last verified
Sep 2023
First submitted
20 Oct 2022
Last updated
6 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Berryhill ME, Martin D. Cognitive Effects of Transcranial Direct Current Stimulation in Healthy and Clinical Populations: An Overview. J ECT. 2018 Sep;34(3):e25-e35. doi: 10.1097/YCT.0000000000000534.

    PubMed 30095685
  • Martin DM, Teng JZ, Lo TY, Alonzo A, Goh T, Iacoviello BM, Hoch MM, Loo CK. Clinical pilot study of transcranial direct current stimulation combined with Cognitive Emotional Training for medication resistant depression. J Affect Disord. 2018 May;232:89-95. doi: 10.1016/j.jad.2018.02.021. Epub 2018 Feb 17.

    PubMed 29477590
  • Pera-Guardiola V, Contreras-Rodriguez O, Batalla I, Kosson D, Menchon JM, Pifarre J, Bosque J, Cardoner N, Soriano-Mas C. Brain Structural Correlates of Emotion Recognition in Psychopaths. PLoS One. 2016 May 13;11(5):e0149807. doi: 10.1371/journal.pone.0149807. eCollection 2016.

    PubMed 27175777
  • Song M, Shin Y, Yun K. Beta-frequency EEG activity increased during transcranial direct current stimulation. Neuroreport. 2014 Dec 17;25(18):1433-6. doi: 10.1097/WNR.0000000000000283.

    PubMed 25383460
  • van der Schalk J, Hawk ST, Fischer AH, Doosje B. Moving faces, looking places: validation of the Amsterdam Dynamic Facial Expression Set (ADFES). Emotion. 2011 Aug;11(4):907-20. doi: 10.1037/a0023853.

    PubMed 21859206
  • Wirth M, Rahman RA, Kuenecke J, Koenig T, Horn H, Sommer W, Dierks T. Effects of transcranial direct current stimulation (tDCS) on behaviour and electrophysiology of language production. Neuropsychologia. 2011 Dec;49(14):3989-98. doi: 10.1016/j.neuropsychologia.2011.10.015. Epub 2011 Oct 21.

    PubMed 22044650
  • Sun C, Zhao Z, Cheng L, Tian R, Zhao W, Du J, Zhang Y, Wang C. Effect of Transcranial Direct Current Stimulation on the Mismatch Negativity Features of Deviated Stimuli in Children With Autism Spectrum Disorder. Front Neurosci. 2022 Feb 9;16:721987. doi: 10.3389/fnins.2022.721987. eCollection 2022.

    PubMed 35221894
  • Boonstra TW, Nikolin S, Meisener AC, Martin DM, Loo CK. Change in Mean Frequency of Resting-State Electroencephalography after Transcranial Direct Current Stimulation. Front Hum Neurosci. 2016 Jun 6;10:270. doi: 10.3389/fnhum.2016.00270. eCollection 2016.

    PubMed 27375462
  • Brennan S, McLoughlin DM, O'Connell R, Bogue J, O'Connor S, McHugh C, Glennon M. Anodal transcranial direct current stimulation of the left dorsolateral prefrontal cortex enhances emotion recognition in depressed patients and controls. J Clin Exp Neuropsychol. 2017 May;39(4):384-395. doi: 10.1080/13803395.2016.1230595. Epub 2016 Sep 23.

    PubMed 27662113
  • Cavinato M, Genna C, Formaggio E, Gregorio C, Storti SF, Manganotti P, Casanova E, Piperno R, Piccione F. Behavioural and electrophysiological effects of tDCS to prefrontal cortex in patients with disorders of consciousness. Clin Neurophysiol. 2019 Feb;130(2):231-238. doi: 10.1016/j.clinph.2018.10.018. Epub 2018 Nov 29.

    PubMed 30580246
  • Donaldson PH, Kirkovski M, Yang JS, Bekkali S, Enticott PG. High-definition tDCS to the right temporoparietal junction modulates slow-wave resting state power and coherence in healthy adults. J Neurophysiol. 2019 Oct 1;122(4):1735-1744. doi: 10.1152/jn.00338.2019. Epub 2019 Aug 28.

    PubMed 31461371
  • Dong G, Wang Y, Chen X. Anodal occipital tDCS enhances spontaneous alpha activity. Neurosci Lett. 2020 Mar 16;721:134796. doi: 10.1016/j.neulet.2020.134796. Epub 2020 Jan 30.

    PubMed 32006627
  • Ferrucci R, Giannicola G, Rosa M, Fumagalli M, Boggio PS, Hallett M, Zago S, Priori A. Cerebellum and processing of negative facial emotions: cerebellar transcranial DC stimulation specifically enhances the emotional recognition of facial anger and sadness. Cogn Emot. 2012;26(5):786-99. doi: 10.1080/02699931.2011.619520. Epub 2011 Nov 14.

    PubMed 22077643
  • Gordon PC, Zrenner C, Desideri D, Belardinelli P, Zrenner B, Brunoni AR, Ziemann U. Modulation of cortical responses by transcranial direct current stimulation of dorsolateral prefrontal cortex: A resting-state EEG and TMS-EEG study. Brain Stimul. 2018 Sep-Oct;11(5):1024-1032. doi: 10.1016/j.brs.2018.06.004. Epub 2018 Jun 18.

    PubMed 29921529
  • Iarrobino I, Bongiardina A, Dal Monte O, Sarasso P, Ronga I, Neppi-Modona M, Actis-Grosso R, Salatino A, Ricci R. Right and left inferior frontal opercula are involved in discriminating angry and sad facial expressions. Brain Stimul. 2021 May-Jun;14(3):607-615. doi: 10.1016/j.brs.2021.03.014. Epub 2021 Mar 27.

    PubMed 33785407

Questions about this trial

What is this clinical trial studying?

A study testing Active tDCS in people with Emotion Recognition, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in EEG Oscillations for active vs. sham stimulation (time frame: Baseline, 5 minutes after completion of the active/sham stimulation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05623072, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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