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Enrolling by Invitation

NCT Number: NCT07405463

Effects of tDCS 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenzhen Kangning Hospital

Guangzhou, Guangdong, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cathodal tDCS (rDLPFC)

Device

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

Anodal tDCS (vmPFC)

Device

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

Sham tDCS

Device

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.

Anodal tDCS (lDLPFC)

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Sponsors and collaborators

Lead sponsor

Jingchu Hu

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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