Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- MEG physiological parameters measurements that will be used in future clinical research protocols
研究概览
简要总结
Feasibility study: the examinations carried out as part of this protocol aim to carry out all the acquisitions and simulations of use, necessary for the development of the clinical research protocols to come to Clinatec (in particular, configuration of the equipment, dimension of the examination time and the size of the cohorts etc ...)
详细描述
To ensure the feasibility of a clinical trial, it is necessary to test the parameters as well as the sequence of the different examination times offered to participants.
The expected results of this protocol are mainly the dimension of experimental paradigms and the optimization of the clinical management of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ⩾ 18 years
- •Affiliated to a social security scheme
- •Free and informed consent signed
排除标准
- •Subject in a period of exclusion from another study.
- •Subject deprived of liberty by a judicial or administrative decision, or major subject subject to a legal protection measure (guardianship, curatorship and safeguarding of justice) referred to in Articles 1121-6 to 1121-8 of the Public Health Code.
- •Subject who would receive more than 4500 euros in compensation because of his participation in other research involving the human person in the 12 months preceding this study.
- •Pregnant woman, parturient, nursing mother (Article 1121-5 of the Public Health Code)
- •Subject not reachable urgently.
研究组 & 干预措施
Healthy Volunteers
tests
干预措施: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability (Other)
Healthy Volunteers
tests
干预措施: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability (Other)
Healthy Volunteers
tests
干预措施: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability (Other)
Healthy Volunteers
tests
干预措施: CE marked Medical Device ElectroCardioGraphy (ECG) usability (Other)
Parkinson's Disease patients
tests
干预措施: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability (Other)
Parkinson's Disease patients
tests
干预措施: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability (Other)
Parkinson's Disease patients
tests
干预措施: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability (Other)
Parkinson's Disease patients
tests
干预措施: CE marked Medical Device ElectroCardioGraphy (ECG) usability (Other)
Para/tetraplegic Patients
tests
干预措施: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability (Other)
Para/tetraplegic Patients
tests
干预措施: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability (Other)
Para/tetraplegic Patients
tests
干预措施: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability (Other)
Para/tetraplegic Patients
tests
干预措施: CE marked Medical Device ElectroCardioGraphy (ECG) usability (Other)
结局指标
主要结局
MEG physiological parameters measurements that will be used in future clinical research protocols
时间窗: through study completion, an average of 10 years
Adequacy of MEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject
ECG physiological parameters measurements that will be used in future clinical research
时间窗: through study completion, an average of 10 years
Adequacy of ECG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject
MRI physiological parameters measurements that will be used in future clinical research
时间窗: through study completion, an average of 10 years
Adequacy of MRI physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject
EEG physiological parameters measurements that will be used in future clinical research
时间窗: through study completion, an average of 10 years
Adequacy of EEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject
次要结局
- MEG physiological parameters data collection paradigms(through study completion, an average of 10 years)
- ECG physiological parameters data collection paradigms(through study completion, an average of 10 years)
- MRI physiological parameters data collection paradigms(through study completion, an average of 10 years)
- EEG physiological parameters data collection paradigms(through study completion, an average of 10 years)