MRIMAP-IRMaGENCT05036629
Development of MRI Protocols and Associated Neuro-physiological Explorations in Healthy and Pathological Subjects
A study testing MRI Protocol in people with MRI and Sequence Optimization, run by University Hospital, Grenoble at 1 site in France.
Trial summary
IRMaGe is a Joint Service Unit (UMS) which provides users of brain exploration equipment (clinical MRI and preclinical, TMS, EEG, NIRS and metabolomics). The methods available on this equipment are intended to evolve according to the most recent discoveries and this protocol aims to frame the developments necessary… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- MRI, Sequence Optimization, Physiological Measurement
- What is being tested?
- MRI Protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2021to 8 Sep 2031
- 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
- Participants with normal or corrected vision
- Participants affiliated to a social security scheme or beneficiaries of such a scheme
- Participants with French as their mother tongue
- Participants who have given the signed informed consent before carrying out any procedure related to the study.
- Volunteer patients will be recruited as part of their follow-up at the CHU. Their pathology will be in agreement with that of the research protocol to be optimized.
Who cannot join
- Criteria relating to contraindications to the explorations provided for by the MRI protocol:
- metallic glitter in the eyes
- retinal operation
- claustrophobia
- wearer of pacemaker or cardiac defribrillator or vascular clip or prosthesis cardiac or insulin pump or implanted device to deliver medication or hearing implant or prosthesis or vascular shunt or paragraph or screws, plate metal or tattoo or piercing or implanted metal object or lead shot hunt
- Alcohol ingestion before the examination
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- Pregnant, lactating and parturient women
- Major protected by law
- Participants under administrative or judicial supervision
- Participation in another ongoing study if the study may interfere with participation in the protocol MAP-IRMaGe.
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
Unité Mixte de Service IRMaGe US 017
La Tronche, 38700
COUSIN EMILIE, PhD, 0613638645 ext. 0033, emilie.cousin@univ-grenoble-alpes.fr
TROPRES IRENE, PhD, 4 76 76 93 08 ext. 0033, irene.tropres@univ-grenoble-alpes.fr
About this study
IRMaGe is a Joint Service Unit (UMS) which provides users of brain exploration equipment (clinical MRI and preclinical, TMS, EEG, NIRS and metabolomics). The methods available on this equipment are intended to evolve according to the most recent discoveries and this protocol aims to frame the developments necessary around clinical MRI for IRMaGe can continue to offer tools at the cutting edge of technology.
Read the detailed description
The studies will be carried out on healthy subjects and voluntary patients, who will have given their consent. Their main objective will be the development and optimization of sequence parameters or design stimulation paradigms in order to optimize the quality and relevance of the images produced taking into account the parameters anatomical, functional or metabolic while respecting the experimental constraints imposed by the protocol concerned (equipment of experimentation, additional physiological measurements, etc.). The main judgement criteria will be measurements inherent in the MRI sequence and a physiological measurement associated in the protocol concerned
- Conditions
- MRI, Sequence Optimization, Physiological Measurement
- Being tested
- MRI Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI ProtocolDevice
Also called Physiological measurement during MRI protocol
Eye-tracker Eyelink (eye movements) BIOPAC : (electrodermal resistance) INVIVO Precess : breathing, arterial pressure, pulse,
- NIRS Oxymon artinis medical system
- tES (transcranial electrical stimulation, Neuroelectrics)
| Study group | Role | What they receive |
|---|---|---|
| MRI protocol | Experimental | Feasibility and use of methods developed in clinical research protocols or cognitive: the reproducibility of the parameters of acquisition, of the design of the activation paradigms development and results according to people will be an important element for the future integration of these methods in clinical or cognitive research protocols. Receives: Device: MRI Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diffusion Tensor Imaging Images
DTi sequences on IRM Achieva 3.0T dStream Philips
Measured: 1 to 3 hours
BOLD Signal
EPI sequences during cognitive protocol on IRM Achieva 3.0T dStream Philips
Measured: 1 to 3 Hours
Anatomical Images
Anatomical MR sequences on IRM Achieva 3.0T dStream Philips
Measured: 1 to 3 hours
Secondary outcomes (5)
Eye movements
Acquired by using eye-tracker (Eye-tracker Eyelink) breathing arteries pressure electrodermal conductance
Measured: During MRI session
Electrodermal resistance
Acquired on BIOPAC device allowing physiological measurements
Measured: During MRI session
Blood Pressure/pulse/Breathing
Acquired on INVIVO Precess
Measured: During MRI session
Near-infrared spectroscopy (NIRS) : Hb OHb concentration measurement
Acquired with NIRS Oxymon artinis medical system
Measured: During MRI session
tES
Transcranial Electrical stimulation, Neuroelectrics
Measured: During MRI session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start9 Sep 2021
- Primary completion8 Sep 2031 (estimated)
- Study completion8 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRIStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Exploratory individual statistical analyzes on MRI data functional. No group analysis possible on these updates of MRI protocols
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036629
- Sponsor's protocol ID
- 38RC20.395
- Other IDs
- 2020-A03555-34
- Acronym
- MAP-IRMaGE
- Status last verified
- Sep 2026
- First submitted
- 24 Aug 2021
- Last updated
- 2 Oct 2026
- 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 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of MRI Protocols and Associated Neuro-physiological Explorations in Healthy and Pathological Subjects
- ClinicalTrials.gov ID
- NCT05036629
- Acronym / sponsor ID
- MAP-IRMaGE / 38RC20.395
- Conditions
- MRI, Sequence Optimization, Physiological Measurement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 8 Sep 2031 (estimated)
- Study completion
- 8 Sep 2031 (estimated)
- First posted
- 5 Sep 2021 (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.
IRMaGe is a Joint Service Unit (UMS) which provides users of brain exploration equipment (clinical MRI and preclinical, TMS, EEG, NIRS and metabolomics). The methods available on this equipment are intended to evolve according to the most recent discoveries and this protocol aims to frame the developments necessary around clinical MRI for IRMaGe can continue to offer tools at the cutting edge of technology.
Detailed description
The studies will be carried out on healthy subjects and voluntary patients, who will have given their consent. Their main objective will be the development and optimization of sequence parameters or design stimulation paradigms in order to optimize the quality and relevance of the images produced taking into account the parameters anatomical, functional or metabolic while respecting the experimental constraints imposed by the protocol concerned (equipment of experimentation, additional physiological measurements, etc.). The main judgement criteria will be measurements inherent in the MRI sequence and a physiological measurement associated in the protocol concerned
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Exploratory individual statistical analyzes on MRI data functional. No group analysis possible on these updates of MRI protocols
| Arm | Type | Receives |
|---|---|---|
| MRI protocol | Experimental | Device: MRI ProtocolFeasibility and use of methods developed in clinical research protocols or cognitive: the reproducibility of the parameters of acquisition, of the design of the activation paradigms development and results according to people will be an important element for the future integration of these methods in clinical or cognitive research protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants with normal or corrected vision
- Participants affiliated to a social security scheme or beneficiaries of such a scheme
- Participants with French as their mother tongue
- Participants who have given the signed informed consent before carrying out any procedure related to the study.
- Volunteer patients will be recruited as part of their follow-up at the CHU. Their pathology will be in agreement with that of the research protocol to be optimized.
Key exclusion criteria (10 listed)
- Criteria relating to contraindications to the explorations provided for by the MRI protocol:
- metallic glitter in the eyes
- retinal operation
- claustrophobia
- wearer of pacemaker or cardiac defribrillator or vascular clip or prosthesis cardiac or insulin pump or implanted device to deliver medication or hearing implant or prosthesis or vascular shunt or paragraph or screws, plate metal or tattoo or piercing or implanted metal object or lead shot hunt
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 ProtocolAlso: Physiological measurement during MRI protocolEye-tracker Eyelink (eye movements) BIOPAC : (electrodermal resistance) INVIVO Precess : breathing, arterial pressure, pulse, * NIRS Oxymon artinis medical system * tES (transcranial electrical stimulation, Neuroelectrics) | Device | MRI protocol |
Primary outcome
Diffusion Tensor Imaging Images
Time frame: 1 to 3 hours
DTi sequences on IRM Achieva 3.0T dStream Philips
BOLD Signal
Time frame: 1 to 3 Hours
EPI sequences during cognitive protocol on IRM Achieva 3.0T dStream Philips
Anatomical Images
Time frame: 1 to 3 hours
Anatomical MR sequences on IRM Achieva 3.0T dStream Philips
5 secondary outcomes
Eye movements
Time frame: During MRI session
Electrodermal resistance
Time frame: During MRI session
Blood Pressure/pulse/Breathing
Time frame: During MRI session
Near-infrared spectroscopy (NIRS) : Hb OHb concentration measurement
Time frame: During MRI session
tES
Time frame: During MRI session
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 Oct 2026.
- 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 MRI Protocol in people with MRI and Sequence Optimization, 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 5 inclusion and 10 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 Oct 2026. 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?
Contact ATTYE ARNAUD, MD, PhD (4 76 76 57 39 ext. 0033, aattye@chu-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion Tensor Imaging Images (time frame: 1 to 3 hours). The study lists 3 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 Oct 2026.