NCT02932085已完成不适用
Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device: A Single Institution, Randomized, Double-blind, Sham-controlled Study Using Multimodal Neuroimaging in Healthy Young Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Metabolic brain changes in magnetic resonance imaging by computational approaches
研究概览
简要总结
This study is a randomized, double-blind, and sham-controlled trial to examine the effects of transcranial magnetic stimulation on the brain of health individuals.
详细描述
The efficacy of repetitive transcranial magnetic stimulation on the brain will be assessed by multimodal neuroimaging in healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 19-39 years
- •Informed consent
排除标准
- •Pregnancy or breastfeeding
- •High fever patient
- •Current and past history of seizure or epilepsy
- •Evidence of epilepsy on EEG
- •Pregnancy or possibility of pregnancy during period
- •Major medical or neurological illnesses
- •Evidence of alcohol intake on alcohol breath test
- •Contraindications to MRI scans and transcranial magnetic stimulation
- •Risk of skin burns
- •Use of medications that could have influenced on the study
研究组 & 干预措施
rTMS + Wash-out period + Sham
Active Comparator
- Five consecutive daily repetitive transcranial magnetic stimulation sessions (Neurostar TMS Therapy System, NeuroStar XPLOR System)
- Two weeks wash-out period
- Five consecutive daily sham stimulation sessions
干预措施: Neurostar TMS Therapy System, NeuroStar XPLOR System (Device)
Sham + Wash-out period + rTMS
Sham Comparator
- Five consecutive daily sham stimulation sessions (Neurostar TMS Therapy System, NeuroStar XPLOR System)
- Two weeks wash-out period
- Five consecutive daily repetitive transcranial magnetic stimulation sessions
干预措施: Neurostar TMS Therapy System, NeuroStar XPLOR System (Device)
结局指标
主要结局
Metabolic brain changes in magnetic resonance imaging by computational approaches
时间窗: after 5 sessions (1 session/day) equals 5 days
次要结局
- Standardized scores on a neuropsychological test battery(after 5 sessions (1 session/day) equals 5 days)
- Functional brain changes in magnetic resonance imaging by computational approaches(after 5 sessions (1 session/day) equals 5 days)
- Analysis of EEG activity(after 5 sessions (1 session/day) equals 5 days)
研究者
Sujung Yoon
Professor
Ewha Womans University Mokdong Hospital
研究点 (1)
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