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NCT05698810 | Recruiting | Healthy Volunteers

Preparation and Feasibility of Exams for Expected Studies
Sponsor:

University Hospital, Grenoble

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 ...)

Condition or disease

Healthy Volunteers

Parkinson's Disease Patients

Para/Tetraplegic Patients

Intervention/treatment

CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability

CE marked Medical Device Magnetic Resonance Imaging (MRI) usability

CE marked Medical Device ElectroEncephaloGraphy (EEG) usability

CE marked Medical Device ElectroCardioGraphy (ECG) usability

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 150 participants
Masking : None (Open Label)
Primary Purpose : Other
Official Title : Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
Actual Study Start Date : March 20, 2023
Estimated Primary Completion Date : March 20, 2033
Estimated Study Completion Date : March 20, 2033
Arm Intervention/treatment

Other: Healthy Volunteers

tests

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

Other: Parkinson's Disease patients

tests

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

Other: Para/tetraplegic Patients

tests

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
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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.
Preparation and Feasibility of Exams for Expected Studies

Location Details

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Preparation and Feasibility of Exams for Expected Studies

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

France,

Clinatec Cea/Chuga

Grenoble, France, 38000