Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
研究概览
简要总结
This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by conducting a pilot randomized-controlled trial (RCT) comparing structural neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized Anxiety Disorder (GAD).
详细描述
Participants will complete structural MRI for neuronavigation. Participants will be randomly assigned to treatment condition. TMS or Sham-TMS sessions will occur daily 5 days/week for 6 weeks. Assessments will occur at pretreatment, weekly during treatment, post-treatment, and 3 month.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with GAD as the principal or co-principal disorder
- •Clinical Global Impression Score ≥ 4
- •Hamilton Anxiety Rating Scale ≥ 18
- •Hamilton Rating Scale for Depression ≤ 17
- •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 past 3 months.
- •Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within 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
研究组 & 干预措施
TMS Therapy
TMS treatment
干预措施: TMS (Device)
TMS-Sham
This is a sham TMS condition
干预措施: TMS (Device)
结局指标
主要结局
Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
时间窗: Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.
Responder Status
时间窗: 3-month follow-up
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.
Remission Status
时间窗: 3-month follow-up
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score \< 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at 3-month follow-up.
Responder Status
时间窗: Post-treatment, 6 weeks
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment.
Remission Status
时间窗: post-treatment, 6 weeks
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score \< 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at post-treatment.
次要结局
未报告次要终点