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NCT Number: NCT05698810

Preparation and Feasibility of Exams for Expected Studies

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 ...)

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Key information

Conditions

Healthy Volunteers Para/Tetraplegic Patients Parkinson's Disease Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability

Other

tests

CE marked Medical Device Magnetic Resonance Imaging (MRI) usability

Other

tests

CE marked Medical Device ElectroEncephaloGraphy (EEG) usability

Other

tests

CE marked Medical Device ElectroCardioGraphy (ECG) usability

Other

tests

Primary outcomes

  1. MEG physiological parameters measurements that will be used in future clinical research protocols

    Time frame: through study completion, an average of 10 years

    Adequacy of MEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject

  2. MRI physiological parameters measurements that will be used in future clinical research

    Time frame: through study completion, an average of 10 years

    Adequacy of MRI physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject

  3. EEG physiological parameters measurements that will be used in future clinical research

    Time frame: through study completion, an average of 10 years

    Adequacy of EEG physiological parameters measurements to the needs of the protocol and duration of the paradigm consistent with the cooperation of the subject

  4. ECG physiological parameters measurements that will be used in future clinical research

    Time frame: through study completion, an average of 10 years

    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 outcomes

  1. MEG physiological parameters data collection paradigms

    Time frame: through study completion, an average of 10 years

    Achieving MEG physiological parameters data collection paradigms

  2. MRI physiological parameters data collection paradigms

    Time frame: through study completion, an average of 10 years

    Achieving MRI physiological parameters data collection paradigms

  3. EEG physiological parameters data collection paradigms

    Time frame: through study completion, an average of 10 years

    Achieving EEG physiological parameters data collection paradigms

  4. ECG physiological parameters data collection paradigms

    Time frame: through study completion, an average of 10 years

    Achieving ECG physiological parameters data collection paradigms

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Commissariat A L'energie Atomique

Registry information

Official study title

Preparation and Feasibility of Exams for Expected Studies (PRELUDE)

Acronym: PRELUDE

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Jan 26, 2023
Registry last updated
Sep 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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