Efficacy and Neural Mechanisms of Navigated Continuous Theta Burst Stimulation (cTBS) for Generalized Anxiety Disorder (GAD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change from Baseline in Resting-State Neural Activity
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of a 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 based on a participant's own MRI scan, to guide the stimulation to a specific target in the brain's auditory association cortex. This area is involved in processing information and may play a role in anxiety.
Participants who enroll will be randomly assigned to one of two groups. One group will receive active 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 related symptoms. They will also undergo Magnetic Resonance Imaging (MRI) scans to help researchers understand how cTBS affects brain activity. A follow-up assessment will be conducted two weeks after the treatment ends to check on symptoms.
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 continuous Theta Burst Stimulation (cTBS) in patients with Generalized Anxiety Disorder (GAD).
A total of 40 patients diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) will be recruited from the First and Second Affiliated Hospitals of Anhui Medical University. After providing informed consent, participants will be randomized in a 1:1 ratio to receive either active cTBS or sham cTBS.
The stimulation target is the left auditory association cortex (posterior superior temporal sulcus), with coordinates derived from previous literature (Neri et al., 2024; MNI coordinates: -62, -40, 10). The TMStarget software will be used to transform these coordinates into each participant's native brain space, and a Brainsight neuronavigation system will guide coil placement for precise targeting.
The active intervention will be delivered using a MagStim Rapid2 stimulator with a 70mm air-cooled figure-of-eight coil. Stimulation intensity will be set at 100% of the individual's resting motor threshold (RMT). The cTBS protocol consists of 3-pulse bursts at 50 Hz, repeated at a 5 Hz frequency, for a total of 600 pulses per session (duration of approximately 41 seconds). The sham intervention will utilize an identical-looking sham coil that produces similar sounds without inducing a significant magnetic field, ensuring the integrity of the blinding.
The treatment schedule consists of three sessions per day, with a 15-minute interval between sessions, for seven consecutive days (from Day 2 to Day 8 of the study protocol).
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.
- •More than 5 years of education.
- •Right-handed.
- •Normal or corrected-to-normal visual acuity.
- •Able to cooperate with the completion of all experimental procedures.
- •Willing and able to provide written informed consent.
排除标准
- •Presence of other psychiatric disorders, such as substance abuse, schizophrenia, schizoaffective disorder, hysteria, or autism.
- •Presence of severe neurological diseases (e.g., stroke), or any personal or family history of epilepsy or seizures.
- •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 depressive stupor or severe claustrophobia.
研究组 & 干预措施
Experimental: Navigated cTBS
Participants will receive active continuous Theta Burst Stimulation (cTBS) guided by a neuronavigation system to the left auditory association cortex. Treatment will be administered three times a day for seven consecutive days.
干预措施: Mapsd Continuous Theta Burst Stimulation (Device)
Sham Comparator: Sham cTBS
Participants will undergo a sham cTBS procedure using a placebo coil that mimics the sound and sensation of the active stimulation but delivers no effective magnetic field. The procedure, including targeting and duration, is identical to the active group to maintain blinding.
干预措施: Sham Navigated Continuous Theta Burst Stimulation (Device)
结局指标
主要结局
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 and network dynamics related to the stimulation target (left auditory cortex) and brain circuits implicated in anxiety.
Change from Baseline in Self-Rating Anxiety Scale (SAS) Score
时间窗: Baseline (Day 1), Post-intervention (Day 9), and a 2-week follow-up.
The SAS is a 20-item self-report scale designed to measure the severity of anxiety symptoms. The standard score ranges from 25 to 100, where higher scores indicate more severe levels of anxiety. The change in standard score from baseline will be assessed.
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
时间窗: Baseline (Day 1), Post-intervention (Day 9), and a 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 will be
Change from Baseline in Hamilton Anxiety Rating Scale (HAMA) Score
时间窗: Baseline (Day 1), Post-intervention (Day 9), and a 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 will be
Change from Baseline in Self-Rating Anxiety Scale (SAS) Score
时间窗: Baseline (Day 1), Post-intervention (Day 9), and a 2-week follow-up.
The SAS is a 20-item self-report scale designed to measure the severity of anxiety symptoms. The standard score ranges from 25 to 100, where higher scores indicate more severe levels of anxiety. The change in standard score from baseline 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 and network dynamics related to the stimulation target (left auditory cortex) and brain circuits implicated in anxiety.
次要结局
- Change from Baseline in Four-Dimensional Symptom Questionnaire (4DSQ) Somatization Subscale Score(Baseline (Day 1) and Post-intervention (Day 9).)
- Change from Baseline in Hamilton Depression Rating Scale (HAMD-17) Score(Baseline (Day 1) and Post-intervention (Day 9).)
- 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).)
- Change from Baseline in Patient Health Questionnaire-15 (PHQ-15) Score(Baseline (Day 1) and Post-intervention (Day 9).)
- Change from Baseline in Hamilton Depression Rating Scale (HAMD-17) Score(Baseline (Day 1) and Post-intervention (Day 9).)
- Change from Baseline in Four-Dimensional Symptom Questionnaire (4DSQ) Somatization Subscale 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
Prof.
Anhui Medical University