Prospective Cohort Study of Response and Tolerability of Accelerated Intermittent Theta-burst Stimulation (1W-AiTBS)
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Vastra Gotaland Region
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Difference in MADRS-S from baseline to six weeks after first iTBS treatment
概览
简要总结
Intermittent theta-burst stimulation (iTBS), a variant of repetitive transcranial magnetic stimulation (rTMS), is a well-documented treatment for depression. The aim of this study is to evaluate the effectiveness of an accelerated iTBS protocol (1W-AiTBS) in routine clinical practice. In the accelerated protocol, patients receive 600 pulses per session, for a total of 30 sessions administered over 5-14 treatment days. Patient inclusion will take place over a maximum period of 1.5 years, with a maximum sample size of 150 patients. The target sample size is at least 36 patients. Patients will complete self-rating questionnaires at screening, before and after treatment, and at 6 weeks, 12 weeks, and 6 months from the first day of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of depression verified through a Mini International Neuropsychiatric Interview (M.I.N.I.)
- •provision of signed informed consent form
- •indication for TMS is depression
排除标准
- •conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil
- •implanted device that is activated or controlled in any way by physiological signals
- •implanted mediation pumps
- •intracardiac lines, even when removed
- •any condition that seriously increases the risk of non-compliance or loss of follow-up
研究组 & 干预措施
1W-AiTBS
Magnetic pulses of 80% of visual motor threshold applied in triplets of 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 20 s over the left DLPFC (F3), given in a maximum of 8 sessions per day (>15 min interval), total of 30 treatments on total of 10 week days.
干预措施: iTBS (intermittent theta-burst stimulation) (Device)
结局指标
主要结局
Difference in MADRS-S from baseline to six weeks after first iTBS treatment
时间窗: 6 weeks
The self-rating version of the Montgomery-Asberg Depression Rating Scale (MADRS-S) is a rating scale (0-54 points), where a higher score indicates worse depressive symptoms
次要结局
- Difference in MADRS-S from baseline to after last iTBS treatment(2 weeks)
- Difference in MADRS-S from baseline to twelve weeks after first iTBS treatment(12 weeks)
- Difference in MADRS-S from baseline to six months after first iTBS treatment(6 months)
- Difference in SDS from baseline to twelve weeks after first iTBS treatment(12 weeks)
- Difference in SDS from baseline to six months after first iTBS treatment(6 months)
- Difference in EQ-VAS from baseline to after last iTBS treatment(2 weeks)
- Difference in EQ-VAS from baseline to six weeks after first iTBS treatment(6 weeks)
- Difference in EQ-VAS from baseline to twelve weeks after first iTBS treatment(12 weeks)
- Difference in EQ-VAS from baseline to six months after first iTBS treatment(6 months)
- Difference in reported potential side effects from baseline to after last iTBS treatment(2 weeks)
- Difference in reported potential side effects from baseline to six weeks after first iTBS treatment(6 weeks)
- Difference in reported potential side effects from baseline to twelve weeks after first iTBS treatment(12 weeks)
- Difference in reported potential side effects from baseline to six months after first iTBS treatment(6 months)
- rTMS associated pain experience(2 weeks)
- Number of patients in remission after last iTBS treatment(2 weeks)
- Number of patients in remission six weeks after first iTBS treatment(6 weeks)
- Number of patients in remission twelve weeks after first iTBS treatment(12 weeks)
- Number of patients in remission six months after first iTBS treatment(6 months)