1 Hz RTMS Feasibility Study on Adolescent Treatment Resistant Major Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Inclusion rate -
研究概览
简要总结
This is an open-label study, in which all participants receives an active treatment with repetitive transcranial magnetic stimulation (rTMS) according to clinical protocol. The aim with this pilotstudy is to investigate the feasibility to perform a trial of low-frequency rTMS on treatment-resistant depression in adolescents. The study includes adolescents 13-19 years old, with average to severe depression.
详细描述
The intervention follows the identical clinical procedure used for adults. Initially, the resting motor threshold will be determined by stimulation over the motor cortex, by finding the minimal intensity that produces a motor response in the corresponding distal wrist muscles. The rTMS will be delivered with a powerMAG research ppTMS stimulator (Mag & More), and a figure-of -eight coil, PMD70-pCool (Mag & More). The intervention is within the intended use of this CE-marked medical device. The research participants will receive 1Hz rTMS with daily sessions on 20-30 consecutive week days. The magnetic pulses will be applied at 120% of the resting motor threshold with a figure-of-eight coil at a 45 degree angle towards the midline. The 1Hz rTMS protocol is applied 6 trains of 1-min duration separated by 30-sec inter-train "off" periods over the right DLPFC (F4 site 5 according to the10-20 system). The total duration of one 1 Hz rTMS session is 8 min 30 s.
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
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent from parents and legal guardian
- •Age 13-19 years
- •Diagnosis of uni- or bipolar depression verified through a Mini International Neuropsychiatric Interview for children and adolescents (MINI-KID)
- •Treatment with at least two SSRIs at an adequate dose for at least 8 weeks
排除标准
- •Epilepsy or medical history of seizures
- •Conductive ferromagnetic or other magnetic sensitive 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 medication pumps
- •Intracardiac lines (even if removed)
- •Active substance use disorder
- •Treatment with any medication that could lower the threshold for seizures
- •Usage of benzodiazepines both as prescribed drug and illegal use
- •Any condition that seriously increases the risk of non-compliance or loss of follow-up
研究组 & 干预措施
Active treatment
Active treatment with Repetitive Transcranial Magnetic Stimulation (rTMS) according to clinical protocol.
干预措施: Repetitive Transcranial Magnetic Stimulation (rTMS) (Device)
结局指标
主要结局
Inclusion rate -
时间窗: two years
Participant inclusion during the course of the study
Attrition rate
时间窗: two years
Participant drop-off during the course of the study
次要结局
- CGAS (Children's Global Assessment Scale) score(4 weeks, 6 weeks)
- MADRS (Montgomery and Asberg Depression Rating Scale) score(at Baseline, 4 weeks, 6 weeks)