Personalized Transcranial Magnetic Stimulation Treatment for Depression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS)
研究概览
简要总结
This proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional Magnetic Resonance Imaging (fMRI) connectome-guided localization approach for accelerated TMS among Asian patients with depression.
Participants will be patients with Major Depressive Disorder not responding to standard treatment, with no exclusions to fMRI or transcranial magnetic stimulation (TMS) (essentially metal implants in the head) and willing to participate in the pilot.
All participants will undergo MRI scans before and after the accelerated TMS treatment. The multi-session hierarchical Bayesian model (MS-HBM) approach will be used to estimate individualized connectome-guided target locations.
Patients will undergo accelerated TMS applied to individualized connectome-guided target locations (based on the MS-HBM approach).
Patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days.
All clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up.
The clinical outcome data will be analyzed using linear regression or repeated analysis of variance (ANOVA) after adjusting for baseline clinical characteristics and socio-demographics. Trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders.
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 —（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.
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS)
时间窗: Baseline, immediately post treatment, 1 month and 3 months post intervention
Clinician rated Depression rating scale, range of scores 0 to 60 with higher scores meaning a worse outcome
次要结局
- Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-16)(Baseline, (Days 1-5 of treatment), immediately after intervention, 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)
- EuroQol- 5 Dimension (EQ-5D)(Baseline, immediately post treatment, 1 month and 3 months post intervention)