Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- MEG physiological parameters measurements that will be used in future clinical research protocols
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Healthy Volunteers
tests
Intervention: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability (Other)
Healthy Volunteers
tests
Intervention: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability (Other)
Healthy Volunteers
tests
Intervention: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability (Other)
Healthy Volunteers
tests
Intervention: CE marked Medical Device ElectroCardioGraphy (ECG) usability (Other)
Parkinson's Disease patients
tests
Intervention: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability (Other)
Parkinson's Disease patients
tests
Intervention: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability (Other)
Parkinson's Disease patients
tests
Intervention: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability (Other)
Parkinson's Disease patients
tests
Intervention: CE marked Medical Device ElectroCardioGraphy (ECG) usability (Other)
Para/tetraplegic Patients
tests
Intervention: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability (Other)
Para/tetraplegic Patients
tests
Intervention: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability (Other)
Para/tetraplegic Patients
tests
Intervention: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability (Other)
Para/tetraplegic Patients
tests
Intervention: CE marked Medical Device ElectroCardioGraphy (ECG) usability (Other)
Outcomes
Primary Outcomes
MEG physiological parameters measurements that will be used in future clinical research protocols
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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)