Effects of Repetitive Transcranial Magnetic Stimulation on the Anxiety State of Older Patients With 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
- 100
- 试验地点
- 1
- 主要终点
- Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups.
研究概览
简要总结
The purpose of this study is to evaluate the effects of low-frequency repetitive transcranial magnetic stimulation on anxiety state in older patients with generalized anxiety disorder.
详细描述
Repetitive transcranial magnetic stimulation can alter nerve cell excitability, improve cerebral blood flow and metabolism, and is widely used in neuropsychiatric research. Studies have shown its efficiency and safety in treating anxiety disorders, however the senior patient group has not been adequately validated. The purpose of this study is to evaluate the effects of low-frequency repetitive transcranial magnetic stimulation on anxiety state in older patients with generalized anxiety disorder.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1）Age≥60 years, regardless of gender.
- •2）Meets the diagnostic criteria for generalized anxiety disorder in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) developed by the American Psychiatric Association.
- •3）HAMA score≥14 and HAMD-17 items score <
- •4）No adjustment in the type and dose of anti-anxiety medication in the 3 months prior to randomization.
- •5）Willing to participate and sign the informed consent.
排除标准
- •1）Traumatic brain injury or other conditions affecting the brain, such encephalitis, brain tumors, or intracranial hypertension.
- •2）Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors or alcohol abuse.
- •3）History of other psychiatric disorders such as current post-traumatic stress disorder, substance use disorder (within 6 months), bipolar disorder and obsessive-compulsive disorder.
- •4）Unstable mental state with impulses toward self-harm or suicide.
- •5）Presence of intracranial metal implant, cochlear implant, built-in pulse generator (such as cardiac pacemaker), etc.
- •6）Medical or surgical disorders that are severe or unstable.
- •7）Pregnancy or breastfeeding.
- •Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment.
- •Other conditions that the researchers think are not suitable for the project.
研究组 & 干预措施
rTMS
Patients are treated with repetitive transcranial magnetic stimulation (rTMS).
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
sham-rTMS
Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).
干预措施: Sham Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups.
时间窗: baseline; 10 days
The HAMA scale consists of 14 items, each with a score ranging from 1 to 4, for a total score ranging from 14 to 56, and the degree of anxiety correlates positively with the score.
次要结局
未报告次要终点
研究者
Yi Yang
Vice President of First Hospital of Jilin University
The First Hospital of Jilin University