Healthy VolunteersPRELUDENCT05698810
Preparation and Feasibility of Exams for Expected Studies
A study testing CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability, CE marked Medical Device Magnetic Resonance Imaging (MRI) usability and CE marked Medical Device ElectroEncephaloGraphy (EEG) usability in people with Healthy Volunteers and Parkinson's Disease Patients, run by University Hospital, Grenoble at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Parkinson's Disease Patients, Para/Tetraplegic Patients
- What is being tested?
- CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability, CE marked Medical Device Magnetic Resonance Imaging (MRI) usability and CE marked Medical Device ElectroEncephaloGraphy (EEG) usability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2023to 20 Mar 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ⩾ 18 years
- Affiliated to a social security scheme
- Free and informed consent signed
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinatec Cea/Chuga
Grenoble, 38000
Stéphan CHABARDES, MD, PhD, +33476767559, SChabardes@chu-grenoble.fr
Caroline SANDRE-BALLESTER, PhD, 0438782851, csandreballester@chu-grenoble.fr
About this study
Official title: 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 ...)
Read the 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.
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CE marked Medical Device MagnetoEncephaloGraphy (MEG) usabilityOther
tests
CE marked Medical Device Magnetic Resonance Imaging (MRI) usabilityOther
tests
CE marked Medical Device ElectroEncephaloGraphy (EEG) usabilityOther
tests
CE marked Medical Device ElectroCardioGraphy (ECG) usabilityOther
tests
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Other | tests Receives: 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 |
| Parkinson's Disease patients | Other | tests Receives: 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 |
| Para/tetraplegic Patients | Other | tests Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 10 years
Secondary outcomes (4)
MEG physiological parameters data collection paradigms
Achieving MEG physiological parameters data collection paradigms
Measured: through study completion, an average of 10 years
MRI physiological parameters data collection paradigms
Achieving MRI physiological parameters data collection paradigms
Measured: through study completion, an average of 10 years
EEG physiological parameters data collection paradigms
Achieving EEG physiological parameters data collection paradigms
Measured: through study completion, an average of 10 years
ECG physiological parameters data collection paradigms
Achieving ECG physiological parameters data collection paradigms
Measured: through study completion, an average of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start20 Mar 2023
- Primary completion20 Mar 2033 (estimated)
- Study completion20 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- volunteers
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698810
- Sponsor's protocol ID
- 38RC22.0130
- Acronym
- PRELUDE
- Status last verified
- Aug 2025
- First submitted
- 13 Dec 2022
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
- ClinicalTrials.gov ID
- NCT05698810
- Acronym / sponsor ID
- PRELUDE / 38RC22.0130
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Study start
- 20 Mar 2023 (actual)
- Primary completion
- 20 Mar 2033 (estimated)
- Study completion
- 20 Mar 2033 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- volunteers
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Other | 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) usabilitytests |
| Parkinson's Disease patients | Other | 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) usabilitytests |
| Para/tetraplegic Patients | Other | 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) usabilitytests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ⩾ 18 years
- Affiliated to a social security scheme
- Free and informed consent signed
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CE marked Medical Device MagnetoEncephaloGraphy (MEG) usabilitytests | Other | Healthy Volunteers, Para/tetraplegic Patients, Parkinson's Disease patients |
| CE marked Medical Device Magnetic Resonance Imaging (MRI) usabilitytests | Other | Healthy Volunteers, Para/tetraplegic Patients, Parkinson's Disease patients |
| CE marked Medical Device ElectroEncephaloGraphy (EEG) usabilitytests | Other | Healthy Volunteers, Para/tetraplegic Patients, Parkinson's Disease patients |
| CE marked Medical Device ElectroCardioGraphy (ECG) usabilitytests | Other | Healthy Volunteers, Para/tetraplegic Patients, Parkinson's Disease patients |
Primary outcome
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
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
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
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
4 secondary outcomes
MEG physiological parameters data collection paradigms
Time frame: through study completion, an average of 10 years
MRI physiological parameters data collection paradigms
Time frame: through study completion, an average of 10 years
EEG physiological parameters data collection paradigms
Time frame: through study completion, an average of 10 years
ECG physiological parameters data collection paradigms
Time frame: through study completion, an average of 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability, CE marked Medical Device Magnetic Resonance Imaging (MRI) usability and CE marked Medical Device ElectroEncephaloGraphy (EEG) usability in people with Healthy Volunteers and Parkinson's Disease Patients, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEG physiological parameters measurements that will be used in future clinical research protocols (time frame: through study completion, an average of 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.