Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder: Substudy #2
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.
研究概览
简要总结
We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.
详细描述
We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participated in the study DIEF003523.1, received sham "placebo" TMS and achieved < 50% improvement in HARS at 3 month follow-up.
- •Fluency in English
- •Capacity to understand the nature of the study and willingness to sign informed consent form
排除标准
- •History of epilepsy or head trauma (LOC > 5 minutes) within the past 6 months
- •Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery
- •A review of patient medications by the study physician indicates an increased risk of seizure
- •An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency
- •Substance use disorder or PTSD within the past 6 months
- •Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder
- •Any psychotic features, including dementia or delirium
- •Concurrent psychotherapy and unwillingness to discontinue
- •Medication change within the past 4 weeks
- •Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the past 6 months
- •Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study
- •Any contraindication for participation in MRI scan
结局指标
主要结局
Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.
时间窗: Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session
The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.
次要结局
未报告次要终点