Development of MRI Protocols and Associated Neuro-physiological Explorations in Healthy and Pathological Subjects (MAP-IRMaGE)

October 17, 2023 updated by: University Hospital, Grenoble
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MRI protocol
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.
Device: 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)
Other Names:
  • Physiological measurement during MRI protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diffusion Tensor Imaging Images
Time Frame: 1 to 3 hours
DTi sequences on IRM Achieva 3.0T dStream Philips
1 to 3 hours
BOLD Signal
Time Frame: 1 to 3 Hours
EPI sequences during cognitive protocol on IRM Achieva 3.0T dStream Philips
1 to 3 Hours
Anatomical Images
Time Frame: 1 to 3 hours
Anatomical MR sequences on IRM Achieva 3.0T dStream Philips
1 to 3 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eye movements
Time Frame: During MRI session
Acquired by using eye-tracker (Eye-tracker Eyelink) breathing arteries pressure electrodermal conductance
During MRI session
Electrodermal resistance
Time Frame: During MRI session
Acquired on BIOPAC device allowing physiological measurements
During MRI session
Blood Pressure/pulse/Breathing
Time Frame: During MRI session
Acquired on INVIVO Precess
During MRI session
Near-infrared spectroscopy (NIRS) : Hb OHb concentration measurement
Time Frame: During MRI session
Acquired with NIRS Oxymon artinis medical system
During MRI session
tES
Time Frame: During MRI session
Transcranial Electrical stimulation, Neuroelectrics
During MRI session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC20.395
  • 2020-A03555-34 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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