Preparation and Feasibility of Exams for Expected Studies (PRELUDE)

Grenoble Alpes University Hospital Center (CHU)

Status: Enrolling

Conditions: Para/Tetraplegic Patients; Healthy Volunteers; Parkinson's Disease Patients

Treatments: Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability; Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability; Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability; Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability

Study type: Interventional

Funder types: Other

Identifiers

NCT05698810

38RC22.0130

Details and patient eligibility

About

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 ...)

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

Healthy Volunteers

Other group

Description:

tests

Treatment:

Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability

Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability

Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability

Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability

Parkinson's Disease patients

Other group

Description:

tests

Treatment:

Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability

Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability

Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability

Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability

Para/tetraplegic Patients

Other group

Description:

tests

Treatment:

Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability

Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability

Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability

Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability