Personalized and Accelerated Transcranial Magnetic Stimulation for Treatment-resistant Anxiety Related Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Beck Anxiety Inventory (BAI)
研究概览
简要总结
This proposal seeks to carry out an open-label single arm study to examine the neurobehavioral changes induced by personalized, causal network mapping guided accelerated intermittent theta burst stimulation (aiTBS) in patients with treatment-resistant anxiety-related disorders.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/ female aged ≥ 21 years and ≤ 70 years
- •Diagnosis of an anxiety-related disorder as validated by the MINI (Specifically, the types of anxiety-related disorders are: generalized anxiety disorder; panic disorderl social anxiety disorder; obsessive compulsive disorder; post-traumatic stress disorder; agoraphobia; anxiety disorder due to another medical condition; other specified anxiety disorders; and unspecified anxiety disorder.)
- •Non-response to adequate trial (4 weeks) of at least two anxiety medication as verified by the study clinician, or psychotherapy for anxiety
- •BAI score of 16 or above
- •Able to give informed consent
- •Able to understand English
排除标准
- •DSM-5 psychotic disorder
- •Significant personality disorder which may hinder the progress of this study
- •Drug or alcohol abuse or dependency (preceding 3 months)
- •Rapid clinical response required, e.g., high suicide risk
- •Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy
- •Metal in the cranium, skull defects, pacemaker, cochlear implant, medication infusion pumps or any other electronic implants/ devices
- •Tattoos containing derromagnetic ink or permanent piercings
- •Currently wearing dental braces
- •Pregnancy
- •Unsuitable for MRI or TMS for any other reasons
- •With recent TMS or ECT treatment within the past 3 months
- •Currently on multiple stimulant medications (2 or more)
- •Participant does not have the capacity to provide consent
研究组 & 干预措施
Individualized neuronavigated intermittent theta burst stimulation (MagPro X100) system for anxiety
Participants will receive an accelerated intermittent theta burst stimulation (iTBS) treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 6 treatment sessions daily for 5 consecutive workdays for a total of 30 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines.
干预措施: Individually Neuronavigated accelerated intermittent theta burst stimulation with MagPro X100 (Device)
结局指标
主要结局
Beck Anxiety Inventory (BAI)
时间窗: Baseline, immediately post-treatment, 1-month and 3-months post-intervention.
The primary outcome will be the response rate as defined as ≥50% reduction from baseline BAI scores pre- and post-iTBS treatment. BAI is an ordinal self-report scale measuring physical and cognitive anxiety symptoms ranging from 0-63. Higher scores mean worse outcome.
次要结局
- Beck Depression Inventory (BDI)(Baseline, immediately post-treatment, 1-month and 3-months post-intervention.)
- Penn State Worry Questionnaire (PSWQ)(Baseline, immediately post-treatment, 1-month and 3-months post-intervention.)
- Mini-Mood and Anxiety Symptom Questionnaire (Mini-MASQ)(Baseline, immediately post-treatment, 1-month and 3-months post-intervention.)
- Hamilton Anxiety Rating Scale (HAM-A)(Baseline, immediately post-treatment, 1-month and 3-months post-intervention.)
- Inventory of Depression and Anxiety Symptoms-II (IDAS-II)(Baseline, immediately post-treatment, 1-month and 3-months post-intervention.)
- Sheehan Disability Scale (SDS)(Baseline, immediately post-treatment, 1-month and 3-months post-intervention.)