Efficacy and Neural Mechanisms of Neuroimage-guided Dual-target Continuous Theta Burst Stimulation (Auditory Cortex and M1) for Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of a dual-target non-invasive brain stimulation technique called continuous Theta Burst Stimulation (cTBS) for treating Generalized Anxiety Disorder (GAD). The researchers will use a neuronavigation system, which acts like a GPS for the brain, to guide the stimulation to two specific targets: the left auditory association cortex and the primary motor cortex (M1).
Participants will be randomly assigned to one of two groups. One group will receive active dual-target cTBS treatment, while the other will receive a sham (placebo) stimulation that feels similar but has no therapeutic effect. The treatment will be given three times a day for seven consecutive days. Before and after the treatment period, all participants will complete clinical questionnaires to measure their anxiety and undergo Magnetic Resonance Imaging (MRI) scans to help researchers understand how cTBS affects brain activity.
详细描述
This study is a randomized, triple-blind, sham-controlled trial designed to evaluate the efficacy and neural mechanisms of neuronavigation-guided dual-target continuous Theta Burst Stimulation (cTBS) in patients with Generalized Anxiety Disorder (GAD).
A total of participants diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) will be recruited. After providing informed consent, participants will be randomized in a 1:1 ratio to receive either active dual-target cTBS or sham cTBS.
The active intervention involves stimulating two sequential targets using a MagStim Rapid2 stimulator with a 70mm air-cooled figure-of-eight coil:
Target 1 (Auditory Cortex): The first target is the left auditory association cortex (posterior superior temporal sulcus), located using a Brainsight neuronavigation system based on individual MRI scans transformed from MNI coordinates (-62, -40, 10).
Target 2 (M1): The second target is the primary motor cortex (M1), located at the site where the resting motor threshold (RMT) is determined.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Generalized Anxiety Disorder (GAD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), confirmed by at least two psychiatrists.
- •Hamilton Anxiety Rating Scale (HAMA) score >
- •Age between 18 and 60 years.
- •Right-handed.
- •More than 5 years of education.
- •Patients are either medication-free or maintain a consistent medication regimen during cTBS treatment.
- •Willing and able to provide written informed consent.
- •Normal or corrected-to-normal visual acuity and hearing.
排除标准
- •Presence of other psychiatric disorders, such as substance abuse, schizophrenia, schizoaffective disorder, hysteria, autism, or bipolar disorder.
- •History of epilepsy, seizures, or severe neurological diseases (e.g., stroke, organic brain lesions).
- •Presence of severe somatic diseases, such as severe heart, liver, or renal insufficiency.
- •Pregnant or lactating women.
- •Contraindications to Transcranial Magnetic Stimulation (TMS) or Magnetic Resonance Imaging (MRI), such as the presence of a cardiac pacemaker, cochlear implant, cerebrovascular metal stent, or metal dentures.
- •Inability to cooperate with experimental procedures due to conditions such as severe claustrophobia.
研究组 & 干预措施
Active Dual-target cTBS
Participants will receive active continuous Theta Burst Stimulation (cTBS) guided by a neuronavigation system. The stimulation targets are the left auditory association cortex followed by the primary motor cortex (M1). Treatment will be administered three times a day for seven consecutive days.
干预措施: Active Dual-target cTBS (Device)
Sham Dual-target cTBS
Participants will undergo a sham cTBS procedure using a placebo coil. The procedure mimics the sound, sensation, and coil placement (dual-target) of the active group but delivers no effective magnetic field.
干预措施: Sham Dual-target cTBS (Device)
结局指标
主要结局
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
时间窗: Baseline (Day 1), Post-intervention (Day 9), and 2-week Follow-up
The HAMA is a 14-item, clinician-administered scale used to assess the severity of anxiety symptoms. Total scores range from 0 to 56, with higher scores indicating more severe anxiety. The change in total score from baseline to post-intervention and follow-up will be assessed.
Change from Baseline in Resting-State Neural Activity
时间窗: Baseline (Day 1) and Post-intervention (Day 9)
Changes in resting-state brain activity will be measured by functional magnetic resonance imaging (fMRI). Analyses will examine neural activity (ALFF/ReHo) and functional connectivity dynamics related to the stimulation targets (left auditory cortex and M1) and brain circuits implicated in anxiety.
次要结局
- Change from Baseline in Hamilton Depression Rating Scale (HAMD-17) Score(Baseline (Day 1) and Post-intervention (Day 9))
- Change from Baseline in Self-Rating Anxiety Scale (SAS) Score(Baseline (Day 1), Post-intervention (Day 9), and 2-week Follow-up)
- Change from Baseline in Patient Health Questionnaire-15 (PHQ-15) Score(Baseline (Day 1) and Post-intervention (Day 9))
- Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) Score(Baseline (Day 1) and Post-intervention (Day 9))
研究者
WANG KAI
Professor
Anhui Medical University