NCT07406464

Brief Summary

This experimental study investigated how MRI-compatible transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (DLPFC) modulates neural and cognitive responses to social criticism in healthy volunteers. Participants underwent two MRI sessions - one with active and one with sham stimulation - in a randomized, double-blind, cross-over design. During stimulation, they completed resting-state and task-based fMRI scans including exposure to critical, neutral, and praising auditory comments, followed by behavioral and self-report measures of rumination, mood, and implicit self-esteem.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2014

Completed
11.7 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

December 1, 2025

Enrollment Period

8 months

First QC Date

November 26, 2025

Last Update Submit

February 5, 2026

Conditions

Keywords

tDCSCriticismneuronavigationDLPFCfMRIMRIDNAASL

Outcome Measures

Primary Outcomes (3)

  • Change in perfusion

    Cerebral blood flow measured using arterial spin labeling (ASL) functional MRI before and after tDCS and after the criticism paradigm. Unit of Measure: mL/100 g/min

    Baseline; during tDCS; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)

  • Neural reactivity to praise and criticism

    Blood-oxygen-level dependent (BOLD) signal change during blocks of praising, neutral, and critical comments measured using task-based fMRI. Unit of Measure: Percent signal change (or beta values from the general linear model)

    Periprocedural

  • Resting-state functional connectivity within emotion-regulation networks

    Functional connectivity strength between prefrontal and limbic regions measured using resting-state fMRI before, during, and after tDCS. Unit of Measure: Fisher-z transformed correlation coefficients

    Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)

Secondary Outcomes (9)

  • Change in momentary rumination

    Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)

  • Implicit self-esteem (Implicit Relational Assessment Procedure, IRAP)

    Baseline and post tDCS

  • Spatial deviation between targeting methods

    Baseline (prior to any intervention)

  • Mood ratings-tension

    Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)

  • Momentary mood ratings - fatigue

    Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)

  • +4 more secondary outcomes

Other Outcomes (8)

  • Serotonin transporter genotype

    Baseline (prior to any intervention)

  • Temperament and Character Inventory (TCI)

    Baseline (prior to any intervention)

  • Perceived criticism sensitivity

    Baseline (prior to any intervention)

  • +5 more other outcomes

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

Participants receive MRI-compatible transcranial direct current stimulation (tDCS) using a NeuroConn DC-Stimulator MR. A constant current of 1.5 mA is applied for 20 minutes with the anodal electrode positioned over the left dorsolateral prefrontal cortex (DLPFC) using neuronavigation and the cathodal electrode positioned over the contralateral supra-orbital area. Stimulation is delivered while participants are in the MRI scanner.

Device: tDCS

Sham tDCS

PLACEBO COMPARATOR

Participants receive sham MRI-compatible transcranial direct current stimulation using a NeuroConn DC-Stimulator MR. The electrodes are positioned identically to the active condition. The current is ramped up and down during the first 30 seconds to mimic the initial sensation of stimulation, after which no current is delivered for the remainder of the 20-minute session. Stimulation is administered while participants are in the MRI scanner.

Device: tDCS

Interventions

tDCSDEVICE

Participants are randomized to receive either active or sham tDCS during MRI scanning. Neuroimaging and behavioral outcomes are used to assess the effects of stimulation on emotion-related brain networks.

Active tDCSSham tDCS

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female participants aged 18-35 years.
  • Right-handed, healthy volunteers.
  • No current or past psychiatric or neurological disorder as assessed by structured clinical interview (M.I.N.I.).
  • MRI-compatible (no metal implants, pacemaker, or contraindications for MRI scanning).
  • Not taking psychotropic medication.
  • Fluent in Dutch.
  • Provided written informed consent.

You may not qualify if:

  • Current or past major depressive episode or any other psychiatric disorder.
  • History of epilepsy or seizures in participant
  • History of neurological illness or neurosurgical intervention.
  • Pregnancy.
  • Claustrophobia or inability to tolerate MRI environment.
  • Metal implants or other MRI-incompatible devices.
  • Skin lesions or dermatological conditions at electrode sites.
  • Unstable medical condition.
  • Use of medication that could influence brain activity or mood.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Gent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 26, 2025

First Posted

February 12, 2026

Study Start

July 9, 2013

Primary Completion

March 2, 2014

Study Completion

March 2, 2014

Last Updated

February 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations