NCT04300946招募中不适用
Effects of the Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers
University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2021年10月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- EEG index of time expectation
研究概览
简要总结
The aim of the study is to check the role of the cerebellum in time prediction in healthy volunteers, by means of magnetic transcranial stimulation targeted on the cerebellum, and recording of behavioural measures indexing time prediction
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant, male or female, between 18 and 60 years old
- •Subject affiliated to a social health insurance scheme (beneficiary or entitled person)
- •Subject who has dated and signed an informed consent form
- •For a woman of childbearing age, negative pregnancy test and effective contraception throughout the study
排除标准
- •- Participant with substance use disorders (as defined by DSM-V)
- •Participants taking benzodiazepines and related substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months before inclusion) or hallucinogenic substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product).
- •Participant with neurological pathology or sequelae
- •Participant with Attention Deficit Hyperactivity Disorder (ADHD)
- •Participant with a borderline personality disorder
- •Participant with disabling sensory impairments, including visual acuity (corrected, if applicable) < 0.8 (due to use of visual material) (Freiburg Vision Test, Bach 1996)
- •Participant deprived of liberty or subject to the safeguard of justice
- •Participant under guardianship or curatorship
- •Participant in a period of exclusion defined by another clinical study or participant in a study that may impact on research results
- •Pregnant or breastfeeding woman
- •Subject with a contraindication to performing an MRI or TMS: presence of non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump, vascular clip or stent, heart valve or ventricular lead, certain intracerebral clips, cochlear implants, history of epilepsy, skin pathology at the point of contact with the electrodes.
- •Subject with a history of major neurological or psychiatric illness with current psychotropic medication (i.e., antidepressant, thyroid regulator, antipsychotic, benzodiazepine and related drugs, or hypnotic).
结局指标
主要结局
EEG index of time expectation
时间窗: 40 minutes
beta oscillation
次要结局
未报告次要终点
研究者
研究点 (1)
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