Dynamic Network Changes During Transcranial Magnetic Stimulation Therapy in Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pre-Post TMS Treatment Effect Measured by HAMD
研究概览
简要总结
This project aims to investigate whether symptom and brain networks and TMS stimulation sites can predict the response to TMS treatment of a transdiagnostic patient group with depressive syndrome. The TMS treatment is no intervention study - the investigators aim to observe patients who receive TMS as part of their psychiatric treatment.
Additionally, the investigators aim to investigate exploratively how symptoms change over the course of treatment with TMS, that is, which symptoms respond first to treatment.
Patients participate in a separate study first (DYNAMIC Central Project, registered with the German Clinical Trials Register: DRKS00038256), where MRI data is acquired. Within this project the symptomatology before, during and after the TMS-treatment are observed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are treated with TMS as an antidepressant will be recruited for study participation. The TMS treatment is carried out regardless of study participation.
- •Men and women will be included in a balanced ratio.
- •German language skills are required to ensure that questionnaires, interviews, and instructions are correctly understood, processed and answered.
排除标准
- •Patients younger than 18 or older than 70 will be excluded
- •Participants who did not participate in the DYNAMIC central project (German Clinical Trials Register DRKS00038256) will be excluded.
- •Further exclusion criteria for participation are acute or chronic neurological diseases.
- •Patients who are pregnant will not be included in the study.
- •As we use app-based questionnaires, we cannot include participants without internet-enabled devices in the study.
结局指标
主要结局
Pre-Post TMS Treatment Effect Measured by HAMD
时间窗: Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks)
Difference Score between pre-TMS and post-TMS on the Hamilton Depression Rating Scale (HAMD). HAMD: Standard interview for assessing current depressive symptoms from the perspective of the practitioner with 17 and 4 additional items (duration approx. 20 min). For this outcome measure, the first 17 items are used to calculate a sum score for interpretation, because cut-off scores exist for the HAMD-17 version. Higher scores reflect greater symptom intensity. The sum scores range between a minimum of 0 and a maximum of 52. A sum score ≤ 8 indicates no depression. A sum score between 9-16 indicates mild depression. A sum score between 17-24 indicates moderate depression. A sum score ≥ 25 indicates severe depression.
次要结局
- Pre-Post TMS Treatment Effect Measured by MADRS(Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks))
- Pre-Post TMS Treatment Effect Measured by IDS-C(Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks))
- Pre-Post TMS Treatment Effect Measured by HAMA(Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks))
- Pre-Post TMS Treatment Effect Measured by YMRS(Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks))
- Pre-Post TMS Treatment Effect Measured by BDI-II(Pre-assessment at baseline before TMS-treatment and Post-assessment within a week after last TMS-treatment (average treatment duration 4-6 weeks))
- Patient and Clinician expected treatment outcome(pre-TMS treatment)
研究者
Jonathan Repple
Prof. Dr. med.
Johann Wolfgang Goethe University Hospital