NCT07405463

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
31mo left

Started Dec 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress16%
Dec 2025Dec 2028

Study Start

First participant enrolled

December 1, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

3 years

First QC Date

February 5, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

Transcranial Direct Current StimulationtDCSFear ReversalAnxietyDorsolateral Prefrontal CortexVentromedial Prefrontal CortexCognitive Flexibility

Outcome Measures

Primary Outcomes (1)

  • Mean Accuracy Rate in the Reversal Phase of the Fear Reversal Task

    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 Outcomes (3)

  • Reaction Time in the Reversal Phase

    During the intervention (Day 1, approximately 25 minutes)

  • Skin Conductance Response (SCR) Amplitude

    During the intervention (Day 1, approximately 25 minutes)

  • Subjective Anxiety Score (VAS)

    During the intervention (Day 1, assessed intermittently during the 25-minute task)

Study Arms (4)

Active Comparator: Cathodal rDLPFC

EXPERIMENTAL

Participants receive inhibitory stimulation over the right dorsolateral prefrontal cortex.

Device: Cathodal tDCS (rDLPFC)

Active Comparator: Anodal vmPFC

EXPERIMENTAL

Participants receive excitatory stimulation over the ventromedial prefrontal cortex.

Device: Anodal tDCS (vmPFC)

Sham Comparator: Sham tDCS

SHAM COMPARATOR

Participants receive a pseudo-stimulation that mimics the sensation of real tDCS but delivers no therapeutic current.

Device: Sham tDCS

Active Comparator: Anodal lDLPFC

ACTIVE COMPARATOR

Participants receive excitatory stimulation over the left dorsolateral prefrontal cortex (positive control).

Device: Anodal tDCS (lDLPFC)

Interventions

Current intensity: 2.0 mA. Duration: 25 minutes. Cathode placed over F4 (10-20 system), Anode over contralateral deltoid.

Active Comparator: Cathodal rDLPFC

Current intensity: 2.0 mA. Duration: 25 minutes. Anode placed over Fpz (10-20 system), Cathode over Oz.

Active Comparator: Anodal vmPFC
Sham tDCSDEVICE

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.

Sham Comparator: Sham tDCS

Current intensity: 2.0 mA. Duration: 25 minutes. Anode placed over F3 (10-20 system), Cathode over contralateral deltoid.

Active Comparator: Anodal lDLPFC

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Kangning Hospital

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Jingchu Hu

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 12, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations