Neuroimage-guided Dual-target Continuous Theta Burst Stimulation for Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Hamilton Anxiety Rating Scale (HAMA)
研究概览
简要总结
The aim of this clinical trial was to determine whether image-guided dual-target cTBS is effective for anxiety disorders. The main questions it aims to answer are:
- Does dual-target cTBS improve patients' anxiety symptoms?
- Does dual-target cTBS improve patients' somatization symptoms?
- Researchers will compare cTBS real and sham stimulation to determine whether cTBS is effective in treating anxiety disorders.
Participants will:
- Received either cTBS treatment or sham stimulation for 7 consecutive days
- Psychological assessment and MRI scan were performed before treatment, within 2 days, 2 weeks and 1 month after treatment
- Adverse reactions during the experiment were recorded
详细描述
This was a randomized, double-blind, sham-controlled clinical trial. Patients with generalized anxiety disorder (GAD) were recruited from the Neurology Outpatient Clinic and Psychiatry Outpatient Clinic at the First Affiliated Hospital of Anhui Medical University, as well as the Psychiatry Outpatient Clinic and Inpatient Ward at the Second Affiliated Hospital of Anhui Medical University. The diagnosis of GAD was based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), independently confirmed by two professional psychiatrists. Patients meeting the inclusion criteria provided written informed consent and were randomly assigned to either a true cTBS treatment group or a sham stimulation group.
Patients will be randomly assigned to receive either active or sham cTBS treatments according to a computer-generated list by an unblinded investigator not involved with study ratings/analysis. The assignment will be executed by utilizing sealed opaque envelopes, each containing the code corresponding to the assigned group for every participant. To ensure the integrity of the double-blind procedure, patients, clinical raters, and all personnel responsible for the clinical care of patients will remain uninformed about the assigned condition until the end point of study. Only cTBS administrators have access to the randomization list. The patients, clinical assessors, and all personnel responsible for clinical care remained blinded to group allocation.
After randomization, patients underwent 7 days of cTBS treatment and completed psychological evaluations and multimodal MRI scans at three time points: baseline, post-treatment, and follow-up. Baseline evaluations were conducted within 24 hours before the first cTBS session, while post-treatment and follow-up evaluations were performed 24 hours after the final cTBS session and four weeks later, respectively.
At each time point (baseline, post-treatment, and follow-up), trained evaluators conducted MRI scans and administered the following scales and behavioral paradigms:
Hamilton Anxiety Rating Scale (HAMA); Hamilton Depression Rating Scale (HAMD); Patient Health Questionnaire-15 (PHQ-15); Self-Rating Anxiety Scale (SAS); Insomnia Severity Index (ISI); MFTM-A (Cognitive Control Capacity); Attention Network Test (ANT).
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
- •the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety
- •HAMA score ≥ 14 (HAMD score < 17).
- •Age range: 18-60 years.
- •Right-handed.
- •Able to cooperate with the collection of general demographic information and neuropsychological testing.
- •Patients are either medication-free or maintain a consistent medication regimen during cTBS treatment.-
排除标准
- •Presence of organic brain lesions detected on MRI.
- •History of alcohol or drug dependence.
- •Diagnosis of other neuropsychiatric disorders, such as epilepsy, autism, obsessive-compulsive disorder, or autoimmune encephalitis.
- •Contraindications to MRI scanning.-
研究组 & 干预措施
active cTBS group
Dual-target active cTBS will be performed over 7 consecutive days
干预措施: Continuous theta-burst stimulation (Other)
sham cTBS group
Sham stimulation of dual-target cTBS was performed for 7 consecutive days using a sham coil
干预措施: sham continuous theta-burst stimulation (Other)
结局指标
主要结局
Hamilton Anxiety Rating Scale (HAMA)
时间窗: 0week, 1week, 3week, 5week
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
Hamilton Anxiety Rating Scale (HAMA)
时间窗: 0week, 1week, 3week, 5week
the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms
次要结局
- Hamilton Depression Rating Scale (HAMD)(0week, 1week, 3week, 5week)
- Self-rating anxiety scale(SAS)(0week, 1week)
- ISI(The insomnia severity index)(0week, 1week)
- Patient Health Questionnaire (PHQ-15)(0week, 1week)
- MFTM-A (Cognitive Control Capacity)(0week, 1week)
- Attention Network Test (ANT)(0week, 1week)
研究者
WANG KAI
phD
Anhui Medical University