Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI
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
- Brain Coordinates
研究概览
简要总结
Healthy controls (HC) will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample.
详细描述
HC subjects (n=10)/yr will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single Human Connectome Project compatible MRI session permitting application of both surface-based and more standard volumetric analyses. Subjects will then participate in an on-line neuro-navigation session in which TMS coil positions (in 10/20 coordinate space) will be recorded corresponding to the following targets: 1) hand-representation of motor strip; 2) 5-cm location; 3) 5.5 cm location; 4) MNI coordinates corresponding to the "Fitzgerald"4 and "Weigand"6 volumetric targets; 5) peak anti-correlated region (calculated from rsfcfMRI data alone); 6) center of our targeted parcel, calculated using surface-based approaches. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample. The Go/No-go criterion is an interclass correlation coefficient (ICC) of >.9 between scalp coordinates determined by on-line neuro-navigation and those determined virtually
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-depressed subjects
排除标准
- •Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder); anorexia nervosa or bulimia nervosa within the last year
- •Unstable medical condition by history, physical exam or laboratory results
- •Contraindications to MRI (based on metal screening form)
- •Meets criteria for claustrophobia
- •Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; lifetime history of IV drug use
- •A neurological or neuromuscular disorder;
- •Require medications for a general medical condition that contraindicate the TMS treatment
- •History of ketamine treatment within 6 mo
- •History of monoamine oxidase inhibitor (MAOI) within the past month
- •Lacks capacity to consent
- •Taking medications that increase the risk of seizures. For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, lmethylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry
结局指标
主要结局
Brain Coordinates
时间窗: Day 1
MRI based brain coordinates will be determined using newly developed neuronavigation software
次要结局
未报告次要终点