Preparation and Feasibility of Exams for Expected Studies

Healthy Volunteers Clinical Trial

— PRELUDE  

Official title:

Preparation and Feasibility of Exams for Expected Studies (PRELUDE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698810
• Other study ID #: 38RC22.0130
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: March 20, 2033

Study information

• Verified date: May 2023
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ...)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 20, 2033
• Est. primary completion date: March 20, 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers
• Parkinson Disease
• Parkinson's Disease Patients

Intervention

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

Locations

Country	Name	City	State
France	Clinatec Cea/Chuga	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Commissariat A L'energie Atomique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEG physiological parameters measurements that will be used in future clinical research protocols	Adequacy of MEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject	through study completion, an average of 10 years
Primary	MRI physiological parameters measurements that will be used in future clinical research	Adequacy of MRI physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject	through study completion, an average of 10 years
Primary	EEG physiological parameters measurements that will be used in future clinical research	Adequacy of EEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject	through study completion, an average of 10 years
Primary	ECG physiological parameters measurements that will be used in future clinical research	Adequacy of ECG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject	through study completion, an average of 10 years
Secondary	MEG physiological parameters data collection paradigms	Achieving MEG physiological parameters data collection paradigms	through study completion, an average of 10 years
Secondary	MRI physiological parameters data collection paradigms	Achieving MRI physiological parameters data collection paradigms	through study completion, an average of 10 years
Secondary	EEG physiological parameters data collection paradigms	Achieving EEG physiological parameters data collection paradigms	through study completion, an average of 10 years
Secondary	ECG physiological parameters data collection paradigms	Achieving ECG physiological parameters data collection paradigms	through study completion, an average of 10 years