Healthy Participant StudyNCT07406464
MRI-tDCS Criticism Study
A study testing tDCS in people with Healthy Participant Study, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Participant Study
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 9 Jul 2013to 2 Mar 2014
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Skin lesions or dermatological conditions at electrode sites.
- Unstable medical condition.
- Use of medication that could influence brain activity or mood.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of tDCS on Substrates of Emotion Processing Using fMRI in Healthy Volunteers
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.
Read the detailed description
This study aimed to examine the effects of non-invasive brain stimulation on emotional and self-referential processing. Healthy right-handed female participants completed two identical MRI sessions separated by at least 48 hours and a maximum of 2 weeks. The localization of the left dorsolateral prefrontal cortex (DLPFC) was determined during the first session. Anatomical data were first acquired using a high-resolution T1-weighted structural scan. Participants were then briefly removed from the MRI scanner to define the stimulation target using two complementary methods: (1) the standard scalp position F3 according to the 10-20 international EEG system, and (2) an individualized neuronavigation procedure targeting the mid-center of the left middle frontal gyrus (Brodmann areas 9/46) based on each participant's structural MRI. For the actual tDCS sessions, only the neuronavigation-derived DLPFC target was used for electrode placement.
In each session, participants received either active or sham MRI-compatible tDCS (1.5 mA, 20 minutes) applied over the left DLPFC with the cathode placed over the contralateral supra-orbital region. The order of stimulation (active vs. sham) was randomized and counterbalanced. The location of the DLPFC electrode placement was based During fMRI, participants completed multiple scans: a T1 structural scan, resting-state sequences (pre-, during-, and post-stimulation), resting-state sequences (pre-, during-, and post-auditory criticism task with blocks of critical, neutral, and praising comments), and an arterial spin labeling (ASL) perfusion sequence.
Self-report measures of state rumination (Momentary Ruminative Self-focus Inventory, MRSI) and mood (visual analogue scales) were collected before and after stimulation and after the criticism paradigm. An implicit self-esteem task (Implicit Relational Assessment Procedure, IRAP) followed the MRI session. Trait questionnaires and a blood sample for DNA (e.g. 5-HTTLPR) analysis were collected at baseline only.
The primary goal was to assess whether active tDCS modulates neural and behavioral markers of self-referential processing and emotional regulation compared with sham stimulation.
No serious adverse events occurred during the study. Minor sensations (tingling, mild scalp discomfort) were transient and self-limited.
- Conditions
- Healthy Participant Study
- Being tested
- tDCS
- Keywords
- tDCS, Criticism, neuronavigation, DLPFC, fMRI, MRI, DNA, ASL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Secondary outcomes (9)
Change in momentary rumination
Momentary rumination assessed using the Perseverative Thinking Questionnaire (PTQ).
Unit of Measure: PTQ total score. A higher score means more rumination.
Measured: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Implicit self-esteem (Implicit Relational Assessment Procedure, IRAP)
Implicit self-esteem assessed using the Implicit Relational Assessment Procedure (IRAP).
Unit of Measure: D-IRAP score (reaction-time-based index): D-IRAP score (typically ranging approximately from -2 to +2)
Measured: Baseline and post tDCS
Spatial deviation between targeting methods
Euclidean distance between the dorsolateral prefrontal cortex (DLPFC) target coordinates derived from EEG 10-20 F3 positioning and MRI-based neuronavigation.
Unit of Measure: Millimeters (mm)
Measured: Baseline (prior to any intervention)
Mood ratings-tension
Self-reported tension measured using a visual analogue scale (VAS) Unit of Measure: Score on a 0-10 scale. A higher score means more tensed.
Measured: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - fatigue
Self-reported fatigue measured using a visual analogue scale (VAS).
Unit of Measure:Score on a 0-10 scale. A higher score means more fatigued.
Measured: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - vigor
Self-reported vigor measured using a visual analogue scale (VAS).
Unit of Measure: Score on a 0-10 scale. A higher score means more vigor.
Measured: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - anger
Self-reported anger measured using a visual analogue scale (VAS).
Unit of Measure: Score on a 0-10 scale. A higher score means more anger.
Measured: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - depressed mood
Self-reported depressed mood measured using a visual analogue scale (VAS).
Unit of Measure: Score on a 0-10 scale. A higher score means more depressed mood.
Measured: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - cheerfulness
Self-reported cheerfulness measured using a visual analogue scale (VAS).
Unit of Measure: Score on a 0-10 scale. A higher score means more cheerfulness.
Measured: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start9 Jul 2013
- Primary completion2 Mar 2014
- Study completion2 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participant StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Principal investigator, Sara De Witte, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406464
- Sponsor's protocol ID
- Approved by UZ Gent EC
- Status last verified
- Dec 2025
- First submitted
- 26 Nov 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of tDCS on Substrates of Emotion Processing Using fMRI in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07406464
- Acronym / sponsor ID
- Approved by UZ Gent EC
- Conditions
- Healthy Participant Study
- Keywords
- tDCS, Criticism, neuronavigation, DLPFC, fMRI, MRI, DNA, ASL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 9 Jul 2013 (actual)
- Primary completion
- 2 Mar 2014 (actual)
- Study completion
- 2 Mar 2014 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study aimed to examine the effects of non-invasive brain stimulation on emotional and self-referential processing. Healthy right-handed female participants completed two identical MRI sessions separated by at least 48 hours and a maximum of 2 weeks. The localization of the left dorsolateral prefrontal cortex (DLPFC) was determined during the first session. Anatomical data were first acquired using a high-resolution T1-weighted structural scan. Participants were then briefly removed from the MRI scanner to define the stimulation target using two complementary methods: (1) the standard scalp position F3 according to the 10-20 international EEG system, and (2) an individualized neuronavigation procedure targeting the mid-center of the left middle frontal gyrus (Brodmann areas 9/46) based on each participant's structural MRI. For the actual tDCS sessions, only the neuronavigation-derived DLPFC target was used for electrode placement.
In each session, participants received either active or sham MRI-compatible tDCS (1.5 mA, 20 minutes) applied over the left DLPFC with the cathode placed over the contralateral supra-orbital region. The order of stimulation (active vs. sham) was randomized and counterbalanced. The location of the DLPFC electrode placement was based During fMRI, participants completed multiple scans: a T1 structural scan, resting-state sequences (pre-, during-, and post-stimulation), resting-state sequences (pre-, during-, and post-auditory criticism task with blocks of critical, neutral, and praising comments), and an arterial spin labeling (ASL) perfusion sequence.
Self-report measures of state rumination (Momentary Ruminative Self-focus Inventory, MRSI) and mood (visual analogue scales) were collected before and after stimulation and after the criticism paradigm. An implicit self-esteem task (Implicit Relational Assessment Procedure, IRAP) followed the MRI session. Trait questionnaires and a blood sample for DNA (e.g. 5-HTTLPR) analysis were collected at baseline only.
The primary goal was to assess whether active tDCS modulates neural and behavioral markers of self-referential processing and emotional regulation compared with sham stimulation.
No serious adverse events occurred during the study. Minor sensations (tingling, mild scalp discomfort) were transient and self-limited.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: tDCSParticipants 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. |
| Sham tDCS | Placebo comparator | Device: tDCSParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSParticipants 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. | Device | Active tDCS, Sham tDCS |
Primary outcome
Change in perfusion
Time frame: Baseline; during tDCS; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
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
Neural reactivity to praise and criticism
Time frame: Periprocedural
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)
Resting-state functional connectivity within emotion-regulation networks
Time frame: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
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
9 secondary outcomes
Change in momentary rumination
Time frame: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Implicit self-esteem (Implicit Relational Assessment Procedure, IRAP)
Time frame: Baseline and post tDCS
Spatial deviation between targeting methods
Time frame: Baseline (prior to any intervention)
Mood ratings-tension
Time frame: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - fatigue
Time frame: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - vigor
Time frame: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - anger
Time frame: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - depressed mood
Time frame: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Momentary mood ratings - cheerfulness
Time frame: Baseline; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Healthy Participant Study, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 7 inclusion and 9 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 12 Feb 2026. 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 Belgium. 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 perfusion (time frame: Baseline; during tDCS; immediately post-tDCS; and immediately post-criticism paradigm (single study visit)). 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?
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 12 Feb 2026.