Preparation and Feasibility of Exams for Expected Studies (PRELUDE)

Preparation and Feasibility of Exams for Expected Studies (PRELUDE)

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 ...)

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Parkinson's Disease Patients; Para/Tetraplegic Patients
• Intervention / Treatment: 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

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
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • Recruiting
    • Clinatec Cea/Chuga
    • Contact: Stéphan CHABARDES, MD, PhD; Phone Number: +33476767559; Email: SChabardes@chu-grenoble.fr
    • Contact: Caroline SANDRE-BALLESTER, PhD; Phone Number: 0438782851; Email: csandreballester@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy Volunteers; tests	Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability; tests; Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability; tests; Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability; tests; Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability; tests
Other: Parkinson's Disease patients; tests	Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability; tests; Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability; tests; Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability; tests; Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability; tests
Other: Para/tetraplegic Patients; tests	Other: CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability; tests; Other: CE marked Medical Device Magnetic Resonance Imaging (MRI) usability; tests; Other: CE marked Medical Device ElectroEncephaloGraphy (EEG) usability; tests; Other: CE marked Medical Device ElectroCardioGraphy (ECG) usability; tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
MEG physiological parameters data collection paradigms	Achieving MEG physiological parameters data collection paradigms	through study completion, an average of 10 years
MRI physiological parameters data collection paradigms	Achieving MRI physiological parameters data collection paradigms	through study completion, an average of 10 years
EEG physiological parameters data collection paradigms	Achieving EEG physiological parameters data collection paradigms	through study completion, an average of 10 years
ECG physiological parameters data collection paradigms	Achieving ECG physiological parameters data collection paradigms	through study completion, an average of 10 years

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Commissariat A L'energie Atomique

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2023
• Primary Completion (Estimated): March 20, 2033
• Study Completion (Estimated): March 20, 2033

Study Registration Dates

• First Submitted: December 13, 2022
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Chemistry Techniques, Analytical; Spectrum Analysis; Diagnostic Techniques, Neurological; Electrodiagnosis; Magnetometry; Magnetic Resonance Spectroscopy; Magnetoencephalography; epicatechin gallate
• Other Study ID Numbers: 38RC22.0130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No