Accelerated Intermittent Theta Burst Stimulation to a Novel DLPFC Target for Anxiety and Trauma-related Disorders: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effectiveness as measured by Beck Anxiety Inventory
研究概览
简要总结
The present pilot study will apply accelerated intermittent theta burst stimulation (aiTBS) to a novel transcranial magnetic stimulation (TMS) target for anxiety derived via causal network mapping.
详细描述
Anxiety-related disorders represent the most common class of mental-health disorders and are associated with high rates of non-response and relapse to current treatments. Transcranial magnetic stimulation (TMS) applied to the dorsolateral prefrontal cortex (dlPFC) has been shown to reduce anxiety comorbid with major depressive disorder (MDD). However, anxiety-specific targets have received insufficient attention.
An anxiety specific transcranial magnetic stimulation (TMS) target was recently derived via causal network mapping and was shown to reduce anxiety versus depression symptoms to a greater extent than the conventional dlPFC target in an MDD sample with comorbid anxiety. While potentially promising, this target has yet to be trialed in an anxiety-related disorder sample.
The current open-label study will be the first to evaluate the preliminary effectiveness and safety of this novel right dorsomedial prefrontal cortex (dmPFC) TMS target. MRI-guided neuronavigation will be used to locate this target in each participant. An accelerated intermittent theta-burst (aiTBS) dosing regimen will be used. Based on a 90% resting motor threshold (adjusted for cortical depth), 50 sessions of iTBS will be administered (1800 pulses per session, with a 50-minute inter-session interval) and delivered in a schedule of 10 sessions per day for 5 consecutive days. Clinical assessments and resting-state functional MRI scans will be conducted before and after aiTBS. Heart rate variability (HRV) and eye-movement measures will be collected before and after aiTBS.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of generalized anxiety disorder (GAD), social anxiety disorder (SAD), panic disorder (PD), and/or post-traumatic stress disorder (PTSD) as defined by DSM-5 criteria.
- •Male or female between 18 and 60 years old.
- •Right-handed.
- •Can understand and sign an informed consent document.
- •Beck Anxiety Inventory (BAI) score of 16 or higher.
- •On a stable medication/psychotherapy regimen for at least 6 weeks prior to baseline visit and throughout the duration of the study.
- •In good general health, as ascertained by medical history.
- •Pharmacological treatment resistance or psychotherapeutic treatment resistance.
排除标准
- •Substance use disorders, eating disorders, significant suicidal ideation, mental disorder due to a medical or neurocognitive condition, lifetime psychosis, bipolar disorder, developmental disorders.
- •History of brain surgery and epilepsy.
- •Presence of metallic foreign bodies, such as cardiac pacemakers and stents.
- •Any medical condition or medication that increases the risk of seizures.
- •Intellectual disability.
- •Current severe somatic disease, such as cancer, heart failure, pneumonia, etc.
- •Severe claustrophobia that prevents the use of MRI.
研究组 & 干预措施
Open-label aiTBS to novel right dmPFC TMS anxiety target
干预措施: transcranial magnetic stimulation (Device)
结局指标
主要结局
Effectiveness as measured by Beck Anxiety Inventory
时间窗: Anxiety symptoms will be measured before the TMS treatment, immediately after 5 days of TMS, 1 week and 4 weeks respectively after completion of the TMS treatment
Measure of severity of anxiety - total score of Beck Anxiety Inventory ranges from 0 to 63 (higher numbers indicate higher severity)
次要结局
- Hamilton Depression Rating Scale (HAMD)(Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation)
- State-Trait Anxiety Inventory (STAI)(Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation)
- Resting-state functional MRI (rsfMRI) scan(Baseline (before treatment) and after 5 days of TMS stimulation)
- Safety as measured by number of participants with Adverse Events(Each afternoon after treatment during the 5 days of treatment)
- Hamilton Anxiety Rating Scale (HAMA)(Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation)
- Sheehan Disability Scale (SDS)(Baseline (before treatment), 5 days of TMS treatment, and 1 and 4 weeks after the end of the TMS stimulation)