Healthy Volunteers, Para/Tetraplegic Patients, Parkinson's Disease Patients
Conditions
Brief summary
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
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.
Interventions
OTHERCE marked Medical Device MagnetoEncephaloGraphy (MEG) usability
tests
OTHERCE marked Medical Device Magnetic Resonance Imaging (MRI) usability
tests
OTHERCE marked Medical Device ElectroEncephaloGraphy (EEG) usability
tests
OTHERCE marked Medical Device ElectroCardioGraphy (ECG) usability
tests
Sponsors
Commissariat A L'energie Atomique
University Hospital, Grenoble
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
volunteers
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECG physiological parameters measurements that will be used in future clinical research | 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 |
| MEG physiological parameters measurements that will be used in future clinical research protocols | 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 |
| MRI physiological parameters measurements that will be used in future clinical research | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MEG physiological parameters data collection paradigms | through study completion, an average of 10 years | Achieving MEG physiological parameters data collection paradigms |
| MRI physiological parameters data collection paradigms | through study completion, an average of 10 years | Achieving MRI physiological parameters data collection paradigms |
| EEG physiological parameters data collection paradigms | through study completion, an average of 10 years | Achieving EEG physiological parameters data collection paradigms |
| ECG physiological parameters data collection paradigms | through study completion, an average of 10 years | Achieving ECG physiological parameters data collection paradigms |
Countries
France
Outcome results
None listed