A Randomized, Double-Blind, Controlled Study of Transcranial Direct Current Stimulation Intervention on Fear Reversal in Patients With Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Mean Accuracy Rate in the Reversal Phase of the Fear Reversal Task
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 ≥
- •Normal or corrected-to-normal vision and hearing. Willingness to provide written informed consent and participate in the study.
排除标准
- •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.
研究组 & 干预措施
Active Comparator: Cathodal rDLPFC
Participants receive inhibitory stimulation over the right dorsolateral prefrontal cortex.
干预措施: Cathodal tDCS (rDLPFC) (Device)
Active Comparator: Anodal vmPFC
Participants receive excitatory stimulation over the ventromedial prefrontal cortex.
干预措施: Anodal tDCS (vmPFC) (Device)
Sham Comparator: Sham tDCS
Participants receive a pseudo-stimulation that mimics the sensation of real tDCS but delivers no therapeutic current.
干预措施: Sham tDCS (Device)
Active Comparator: Anodal lDLPFC
Participants receive excitatory stimulation over the left dorsolateral prefrontal cortex (positive control).
干预措施: Anodal tDCS (lDLPFC) (Device)
结局指标
主要结局
Mean Accuracy Rate in the Reversal Phase of the Fear Reversal Task
时间窗: 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.
次要结局
- 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))
研究者
Jingchu Hu
Dr. Jingchu Hu
Shenzhen Kangning Hospital