A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale
研究概览
简要总结
The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 21 years.
- •DSM-5 diagnosis of current Major Depressive Episode.
- •Montgomery-Asberg Depression Rating Scale score of 20 or more.
- •Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
- •Able to give informed consent.
排除标准
- •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.
- •Unsuitable for MRI.
研究组 & 干预措施
Beam F3 targeting of accelerated iTBS
Patients will receive anatomically-guided (Beam F3) accelerated iTBS.
Participants will receive an accelerated 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 10 treatment sessions daily for 5 consecutive workdays for a total of 50 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: Beam F3 targeted accelerated iTBS (Device)
Individualized connectome-guided accelerated iTBS
Patients will receive individualized connectome-guided accelerated iTBS.
Participants will receive an accelerated 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 10 treatment sessions daily for 5 consecutive workdays for a total of 50 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: Individualized connectome-guided accelerated iTBS (Device)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale
时间窗: Baseline, immediately post treatment, 1 month and 3 months post intervention
Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome
次要结局
- Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)(Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention)
- EQ-5D (EuroQol)(Baseline, immediately post treatment, 1 month and 3 months post intervention)
- Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)(Baseline, immediately post treatment, 1 month and 3 months post intervention)
- Montreal Cognitive Assessment (MoCA)(Baseline, immediately post treatment, 1 month and 3 months post intervention)