Mapping the Neural Circuits of Depression and Anxiety Using Personalized, Accelerated TMS and Deep Phenotyping (ADAPT)
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Phern Chern Tor, MBBS
- 电话号码：+65 6908 2222
- 邮箱：cip@nuhs.edu.sg
学习地点
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Singapore、新加坡
- National University Hospital, Singapore
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接触：
- Phern Chern Tor, MBBS
- 电话号码：+65 6908 2222
- 邮箱：cip@nuhs.edu.sg
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Male/female aged 21-70
- Diagnosis of MDD as validated by MINI
- Non-response to adequate trial (4 weeks) of at least two MDD medication as verified by the study clinician
- BDI score of 20 or above; BAI score of 16 or above
- Able to give informed consent
- Able to understand English
Exclusion Criteria:
- DSM-5 psychotic disorder
- Drug or alcohol abuse or dependence (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 pump or other electronic device
- Pregnancy
- Unsuitable for MRI
- With recent TMS or ECT treatment in past 3 months
- Multiple stimulant medications
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Dysphoric target
Participants will receive individualized connectome-guided accelerated iTBS at their dysphoric target. Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterflu 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 50Hz, repeated at 5Hz; 2s on and 8s off; 1800 puolses 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. |
Magpro X100, Axilium Cobot, Localite Camera
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实验性的：Anxiosomatic target
Participants will receive individualized connectome-guided accelerated iTBS at their anxiosomatic target. Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterflu 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 50Hz, repeated at 5Hz; 2s on and 8s off; 1800 puolses 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. |
Magpro X100, Axilium Cobot, Localite Camera
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Rank- Transformed Ratio of Beck Depression Inventory (BDI) to Beck Anxiety Inventory (BAI) change
大体时间：Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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The primary outcome will be the rank-transformed ratio of BDI change to BAI change (e.g.
A patient has a 50% reduction in BDI and a 25% reduction in BAI, giving a BDI:BAI ratio of 50% ÷ 25% = 2.0.
Another patient has a 40% reduction in BDI and a 25% reduction in BAI, giving a BDI:BAI ratio of 40% ÷ 25% = 1.6.
Higher ratios indicate a relatively greater improvement in depression compared with anxiety within each patient.
This ratio is then ranked across all patients.).
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Inventory of Depression and Anxiety Symptoms-II (IDAS-II)
大体时间：Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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IDAS-II is an ordinal self-report scale measuring depression, anxiety, and bipolar symtpoms ranging from 99-495.
Higher scores mean worse outcome.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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Penn State Worry Questionnaire (PSWQ)
大体时间：Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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PSWQ is an ordinal self-report scale measuring pathological worry ranging from 16-80.
Scores depend on whether the item is worded positively or negatively.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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Interaction between TMS target and change in BDI and BAI
大体时间：Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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The investigators will test interactions between TMS Target and change in BDI and BAI (including baseline and weekly outcomes over one month) separately using repeated measures linear mixed effects models.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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TMS induced changes in resting-fMRI functional connectivity
大体时间：Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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The investigators will perform additional exploratory post-hoc analyses by analysing brain imaging changes before and after TMS treatment.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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Passive physiological metrics
大体时间：Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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The investigators will also perform additional exploratory post-hoc analyses by analysing passive physiological data collected using an Oura ring throughout the study duration.
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Baseline (before treatment), immediately after acute treatment (after 30 treatments over 1 week), and weekly during the 1-month follow-up period.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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