Neurostar Transcranial Magnetic Stimulation (TMS) Advanced Therapy System: Data Management, Analysis, and Reporting Format for Clinical Treatment Utilization and Outcomes in the UK
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Neuronetics
- 试验地点
- 1
- 主要终点
- Clinical Global Impression - Severity Scale
研究概览
简要总结
The major objective of this observational study is to describe clinical outcomes of patients in the UK receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.
详细描述
This is a single-center, naturalistic, observational study following the use of the NeuroStar® Advanced Therapy System and assessment of clinical outcome. The goal is to collect, analyze and report information as aggregated summaries on participants receiving treatment with the NeuroStar® Advanced Therapy System.
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
- 22 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, age 22 - 70, out-patient
- •Participants who meet the DSM-5 clinical diagnostic criteria, in the opinion of the treating clinician, for primary diagnosis of unipolar, non-psychotic MDD. The intended treatment plan uses the labeled treatment parameters for TMS as described in the NeuroStar® System
- •Women of child bearing potential must be using a medically accepted reliable means of contraception (for oral contraceptive medication: must be in use for at least 3 months)
- •Women of childbearing potential must have a negative pregnancy test at screening using urine dipstick
- •Participants must have the capacity to consent to all tests and examinations required by the protocol and must sign a written informed consent document to participate in the study.
排除标准
- •History of seizures or increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure or history of significant head trauma with loss of consciousness for ≥ 5 minutes
- •Inability to locate and quantify a motor threshold as defined in the protocol
- •Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the participant's head within 30 cm of the treatment coil excluding the mouth that cannot safely be removed. Examples include: cochlear implants; implanted electrodes/stimulators; aneurysm clips or coils; stents; bullet fragments; jewelry; and hair barrettes
- •Any psychiatric disorder which, in the judgement of the Investigator, may hinder the participant from completing the procedures required by the study protocol
- •Active or inactive implants (including device leads), including deep brain stimulators, and vagus nerve stimulators
- •Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease
- •Known or suspected pregnancy
结局指标
主要结局
Clinical Global Impression - Severity Scale
时间窗: Baseline, 6 weeks, 3, 6, 9, and 12 months
The change from baseline to endpoint on the total score for the Clinical Global Impression - Severity scale will be reported for the 6 week 3, 6, 9, and 12 month time points. The 7-point scale requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. The scale ranges from 1-7, where a higher score means a worse outcome.
次要结局
- Patient Health Questionnaire - 9-item Self Report(Baseline, 6 weeks, 3, 6, 9, and 12 months)
- Short Form 36-item Questionnaire(Baseline, 6 weeks, 3, 6, 9, and 12 months)
- Inventory of Depressive Symptomatology - Self Report (IDS-SR)(Baseline, 6 weeks, 3, 6, 9, and 12 months)
- EuroQol 5 Dimensions(Baseline, 6 weeks, 3, 6, 9, and 12 months)
- Health Resource Utilization Questionnaire (HRU)(Baseline, 6 weeks, 3, 6, 9, and 12 months)