Preparation and Feasibility of Exams for Expected Studies

Study Overview
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Brief Summary
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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 ...)

Detailed Description
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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.

Official Title
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Preparation and Feasibility of Exams for Expected Studies (PRELUDE)

Conditions
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Healthy Volunteers, Parkinson's Disease Patients, Para/Tetraplegic Patients

Intervention / Treatment
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* Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability
* Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability
* Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability
* Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ⩾ 18 years Affiliated to a social security scheme Free and informed consent signed Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Healthy Volunteers<br>tests | Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability<br>* tests<br>Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability<br>* tests<br>Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability<br>* tests<br>Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability<br>* tests<br>|
| Other: Parkinson's Disease patients<br>tests | Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability<br>* tests<br>Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability<br>* tests<br>Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability<br>* tests<br>Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability<br>* tests<br>|
| Other: Para/tetraplegic Patients<br>tests | Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability<br>* tests<br>Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability<br>* tests<br>Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability<br>* tests<br>Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability<br>* tests<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEG physiological parameters measurements that will be used in future clinical research protocols | Adequacy of MEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject | through study completion, an average of 10 years | 
| MRI physiological parameters measurements that will be used in future clinical research | Adequacy of MRI physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject | through study completion, an average of 10 years | 
| EEG physiological parameters measurements that will be used in future clinical research | Adequacy of EEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject | through study completion, an average of 10 years | 
| ECG physiological parameters measurements that will be used in future clinical research | Adequacy of ECG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject | through study completion, an average of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MEG physiological parameters data collection paradigms | Achieving MEG physiological parameters data collection paradigms | through study completion, an average of 10 years | 
| MRI physiological parameters data collection paradigms | Achieving MRI physiological parameters data collection paradigms | through study completion, an average of 10 years | 
| EEG physiological parameters data collection paradigms | Achieving EEG physiological parameters data collection paradigms | through study completion, an average of 10 years | 
| ECG physiological parameters data collection paradigms | Achieving ECG physiological parameters data collection paradigms | through study completion, an average of 10 years |