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Preparation and Feasibility of Exams for Expected Studies (PRELUDE)

Primary Purpose

Healthy Volunteers, Parkinson's Disease Patients, Para/Tetraplegic Patients

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
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
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Volunteers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Clinatec Cea/ChugaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Healthy Volunteers

Parkinson's Disease patients

Para/tetraplegic Patients

Arm Description

tests

tests

tests

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

MEG physiological parameters data collection paradigms
Achieving MEG physiological parameters data collection paradigms
MRI physiological parameters data collection paradigms
Achieving MRI physiological parameters data collection paradigms
EEG physiological parameters data collection paradigms
Achieving EEG physiological parameters data collection paradigms
ECG physiological parameters data collection paradigms
Achieving ECG physiological parameters data collection paradigms

Full Information

First Posted
December 13, 2022
Last Updated
May 9, 2023
Sponsor
University Hospital, Grenoble
Collaborators
Commissariat A L'energie Atomique
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1. Study Identification

Unique Protocol Identification Number
NCT05698810
Brief Title
Preparation and Feasibility of Exams for Expected Studies
Acronym
PRELUDE
Official Title
Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 20, 2023 (Actual)
Primary Completion Date
March 20, 2033 (Anticipated)
Study Completion Date
March 20, 2033 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Commissariat A L'energie Atomique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers, Parkinson's Disease Patients, Para/Tetraplegic Patients

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
volunteers
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Other
Arm Description
tests
Arm Title
Parkinson's Disease patients
Arm Type
Other
Arm Description
tests
Arm Title
Para/tetraplegic Patients
Arm Type
Other
Arm Description
tests
Intervention Type
Other
Intervention Name(s)
CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability
Intervention Description
tests
Intervention Type
Other
Intervention Name(s)
CE marked Medical Device Magnetic Resonance Imaging (MRI) usability
Intervention Description
tests
Intervention Type
Other
Intervention Name(s)
CE marked Medical Device ElectroEncephaloGraphy (EEG) usability
Intervention Description
tests
Intervention Type
Other
Intervention Name(s)
CE marked Medical Device ElectroCardioGraphy (ECG) usability
Intervention Description
tests
Primary Outcome Measure Information:
Title
MEG physiological parameters measurements that will be used in future clinical research protocols
Description
Adequacy of MEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject
Time Frame
through study completion, an average of 10 years
Title
MRI physiological parameters measurements that will be used in future clinical research
Description
Adequacy of MRI physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject
Time Frame
through study completion, an average of 10 years
Title
EEG physiological parameters measurements that will be used in future clinical research
Description
Adequacy of EEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject
Time Frame
through study completion, an average of 10 years
Title
ECG physiological parameters measurements that will be used in future clinical research
Description
Adequacy of ECG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject
Time Frame
through study completion, an average of 10 years
Secondary Outcome Measure Information:
Title
MEG physiological parameters data collection paradigms
Description
Achieving MEG physiological parameters data collection paradigms
Time Frame
through study completion, an average of 10 years
Title
MRI physiological parameters data collection paradigms
Description
Achieving MRI physiological parameters data collection paradigms
Time Frame
through study completion, an average of 10 years
Title
EEG physiological parameters data collection paradigms
Description
Achieving EEG physiological parameters data collection paradigms
Time Frame
through study completion, an average of 10 years
Title
ECG physiological parameters data collection paradigms
Description
Achieving ECG physiological parameters data collection paradigms
Time Frame
through study completion, an average of 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Clinatec Cea/Chuga
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphan CHABARDES, MD, PhD
Phone
+33476767559
Email
SChabardes@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Caroline SANDRE-BALLESTER, PhD
Phone
0438782851
Email
csandreballester@chu-grenoble.fr

12. IPD Sharing Statement

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Preparation and Feasibility of Exams for Expected Studies

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