Magnetic Resonance ImagingMAP-VSNCT03152539
Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Healthy Volunteers
A study testing MRI, EEG and NIRS in people with Magnetic Resonance Imaging, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The main objective of the studies that will be carried out on volunteer patients who have given their consent will be the development and optimization of the sequence parameters or the design of the stimulation paradigms in order to optimize the quality and Relevance of the images realized taking into account… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging
- What is being tested?
- MRI, EEG and NIRS
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 733 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2012to 8 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- major
- socially insured persons
- given their consent.
- absence of contraindication to the MRI examination
Who cannot join
- Subjects under the age of 18
- pregnant women
- all other persons referred to in articles L1121-5 to L1121-8 of the CSP
Trial locations and contacts
1 site in 1 country.
About this study
The main objective of the studies that will be carried out on volunteer patients who have given their consent will be the development and optimization of the sequence parameters or the design of the stimulation paradigms in order to optimize the quality and Relevance of the images realized taking into account anatomical, functional or metabolic parameters. These adjustments will be carried out without interfering with the management of voluntary patients
Read the detailed description
The pathologies that interest us in these refinements concern mainly the chronic (or sequellar) brain disorders which can be degenerative, developmental or vascular. The patients who will be recruited will be known patients of our Service (University Clinic of Neuroradiology and MRI) that we follow during checks. The type of examination that will be applied to them, between MRI, EEG and NIRS, will be specified in the consent form. These examinations will not be invoiced either to the patient or to the social security, and the related costs will be borne by our Federative Research Structure or sometimes, when these explorations are upstream of a defined research protocol and funded, They will be financed under this protocol.
- Conditions
- Magnetic Resonance Imaging
- Being tested
- MRI, EEG, NIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
EEGDevice
NIRSDevice
| Study group | Role | What they receive |
|---|---|---|
| Development of MRI protocols | Experimental | MRI exam to grade differents interventions for future research Receives: Radiation: MRI |
| Development of EEG protocols | Experimental | EEF exam to grade differents interventions for future research Receives: Device: EEG |
| Development of NIRS protocols | Experimental | NIRS exam to grade differents interventions for future research Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatial resolution of new MRI imaging sequences MRI scanning.
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start7 Jun 2012
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Methodological development of new MRI approaches
- Masking
- None (open label)
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03152539
- Sponsor's protocol ID
- 38RC12.238
- Acronym
- MAP-VS
- Status last verified
- Oct 2021
- First submitted
- 24 Apr 2017
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of MRI Protocols and Associated Explorations (EEG, NIRS) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03152539
- Acronym / sponsor ID
- MAP-VS / 38RC12.238
- Conditions
- Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 7 Jun 2012 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 15 May 2017 (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.
The main objective of the studies that will be carried out on volunteer patients who have given their consent will be the development and optimization of the sequence parameters or the design of the stimulation paradigms in order to optimize the quality and Relevance of the images realized taking into account anatomical, functional or metabolic parameters. These adjustments will be carried out without interfering with the management of voluntary patients
Detailed description
The pathologies that interest us in these refinements concern mainly the chronic (or sequellar) brain disorders which can be degenerative, developmental or vascular. The patients who will be recruited will be known patients of our Service (University Clinic of Neuroradiology and MRI) that we follow during checks. The type of examination that will be applied to them, between MRI, EEG and NIRS, will be specified in the consent form. These examinations will not be invoiced either to the patient or to the social security, and the related costs will be borne by our Federative Research Structure or sometimes, when these explorations are upstream of a defined research protocol and funded, They will be financed under this protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Methodological development of new MRI approaches
| Arm | Type | Receives |
|---|---|---|
| Development of MRI protocols | Experimental | Radiation: MRIMRI exam to grade differents interventions for future research |
| Development of EEG protocols | Experimental | Device: EEGEEF exam to grade differents interventions for future research |
| Development of NIRS protocols | Experimental | Device: NIRSNIRS exam to grade differents interventions for future research |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- major
- socially insured persons
- given their consent.
- absence of contraindication to the MRI examination
Key exclusion criteria (3 listed)
- Subjects under the age of 18
- pregnant women
- all other persons referred to in articles L1121-5 to L1121-8 of the CSP
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 |
|---|---|---|
| MRI | Radiation | Development of MRI protocols |
| EEG | Device | Development of EEG protocols |
| NIRS | Device | Development of NIRS protocols |
Primary outcome
Spatial resolution of new MRI imaging sequences MRI scanning.
Time frame: Two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, EEG and NIRS in people with Magnetic Resonance Imaging, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 20 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spatial resolution of new MRI imaging sequences MRI scanning. (time frame: Two hours). 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 20 Oct 2021.