Clinical trial NCT05698810: Preparation and Feasibility of Exams for Expected Studies
Official title: Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volunteers
Parkinson's Disease Patients
Para/Tetraplegic Patients
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Commissariat A L'energie Atomique
First posted: 2023-01-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: volunteers
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: MEG physiological parameters measurements that will be used in future clinical research protocols
timeFrame: through study completion, an average of 10 years
measure: MRI physiological parameters measurements that will be used in future clinical research
timeFrame: through study completion, an average of 10 years
measure: EEG physiological parameters measurements that will be used in future clinical research
timeFrame: through study completion, an average of 10 years
measure: ECG physiological parameters measurements that will be used in future clinical research
timeFrame: through study completion, an average of 10 years
Secondary outcomes:
measure: MEG physiological parameters data collection paradigms
timeFrame: through study completion, an average of 10 years
measure: MRI physiological parameters data collection paradigms
timeFrame: through study completion, an average of 10 years
measure: EEG physiological parameters data collection paradigms
timeFrame: through study completion, an average of 10 years
measure: ECG physiological parameters data collection paradigms
timeFrame: through study completion, an average of 10 years
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinatec Cea/Chuga
Study officials:
References: