Effects of tDCS on Fear Reversal in Patients With Anxiety Disorders

February 5, 2026 updated by: Jingchu Hu

A Randomized, Double-Blind, Controlled Study of Transcranial Direct Current Stimulation Intervention on Fear Reversal in Patients With Anxiety Disorders

This study evaluates the effects of single-session Transcranial Direct Current Stimulation (tDCS) on fear reversal learning in patients with anxiety disorders. Participants will be randomized into four groups to receive either active stimulation targeting specific brain regions (right DLPFC or vmPFC), an active control stimulation, or sham stimulation. The main goal is to determine if modulating these brain areas can improve the ability to update safety and threat associations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Anxiety disorders are characterized by deficits in fear regulation and cognitive flexibility, specifically the inability to inhibit fear responses when a threat becomes safe (fear reversal). Neurobiological models suggest this is linked to hyperactivity in the right dorsolateral prefrontal cortex (rDLPFC) and hypoactivity in the ventromedial prefrontal cortex (vmPFC).

This randomized, double-blind, sham-controlled study aims to verify if tDCS can improve fear reversal performance. The study involves 140 patients with anxiety disorders assigned to one of four arms:

Cathodal tDCS over the right DLPFC (inhibitory); Anodal tDCS over the vmPFC (excitatory); Sham tDCS (placebo); Anodal tDCS over the left DLPFC (active control). During the 25-minute stimulation session, participants will perform a computerized fear reversal task. Physiological data (Skin Conductance Response) and subjective anxiety ratings will be recorded simultaneously to assess the intervention's impact on cognitive and emotional regulation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Shenzhen Kangning Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Age between 18 and 60 years old. Right-handed. Meeting the DSM-5 diagnostic criteria for Gambling Disorder (GD). South Oaks Gambling Screen (SOGS) score ≥ 5. Normal or corrected-to-normal vision and hearing. Willingness to provide written informed consent and participate in the study.

Exclusion Criteria:

History of other severe psychiatric disorders (e.g., schizophrenia, bipolar disorder, severe depression) or neurological diseases (e.g., epilepsy, stroke, brain tumor).

History of substance abuse or dependence (excluding nicotine) in the past 6 months.

Current use of psychotropic medications that may affect cortical excitability (e.g., antidepressants, antipsychotics, anticonvulsants).

Presence of metallic implants in the head or neck area (e.g., cochlear implants, aneurysm clips) or cardiac pacemakers.

Skin lesions or sensitivity at the stimulation sites on the scalp. Pregnancy or lactation. Participation in other neuromodulation studies within the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Active Comparator: Cathodal rDLPFC
Participants receive inhibitory stimulation over the right dorsolateral prefrontal cortex.
Device: Cathodal tDCS (rDLPFC)
Current intensity: 2.0 mA. Duration: 25 minutes. Cathode placed over F4 (10-20 system), Anode over contralateral deltoid.
Experimental: Active Comparator: Anodal vmPFC
Participants receive excitatory stimulation over the ventromedial prefrontal cortex.
Device: Anodal tDCS (vmPFC)
Current intensity: 2.0 mA. Duration: 25 minutes. Anode placed over Fpz (10-20 system), Cathode over Oz.
Sham Comparator: Sham Comparator: Sham tDCS
Participants receive a pseudo-stimulation that mimics the sensation of real tDCS but delivers no therapeutic current.
Device: Sham tDCS
Current ramps up for 30 seconds and then fades to zero to mimic skin sensation, with no sustained current for the rest of the 25 minutes.
Active Comparator: Active Comparator: Anodal lDLPFC
Participants receive excitatory stimulation over the left dorsolateral prefrontal cortex (positive control).
Device: Anodal tDCS (lDLPFC)
Current intensity: 2.0 mA. Duration: 25 minutes. Anode placed over F3 (10-20 system), Cathode over contralateral deltoid.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Accuracy Rate in the Reversal Phase of the Fear Reversal Task
Time Frame: During the intervention (Day 1, approximately 25 minutes)
The percentage of correct responses during the reversal phase of the computerized task, where participants must inhibit previous fear associations and learn new safety signals. Higher scores indicate better cognitive flexibility.
During the intervention (Day 1, approximately 25 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reaction Time in the Reversal Phase
Time Frame: During the intervention (Day 1, approximately 25 minutes)
The response time (in milliseconds) to the new CS+ (formerly CS-) and new CS- (formerly CS+) stimuli during the reversal phase.
During the intervention (Day 1, approximately 25 minutes)
Skin Conductance Response (SCR) Amplitude
Time Frame: During the intervention (Day 1, approximately 25 minutes)
The amplitude of physiological skin conductance responses to Conditioned Stimuli (CS+ and CS-), serving as an objective measure of physiological arousal and fear response.
During the intervention (Day 1, approximately 25 minutes)
Subjective Anxiety Score (VAS)
Time Frame: During the intervention (Day 1, assessed intermittently during the 25-minute task)
Self-reported anxiety levels measured using a Visual Analog Scale (VAS). Scores range from 0 (no anxiety) to 10 (extreme anxiety).
During the intervention (Day 1, assessed intermittently during the 25-minute task)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jingchu Hu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KN2025407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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