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

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: Recruiting
• Conditions: MRI; Sequence Optimization; Physiological Measurement
• Intervention / Treatment: Device: MRI Protocol

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: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ATTYE ARNAUD, MD, PhD; Phone Number: 0033 4 76 76 57 39; Email: aattye@chu-grenoble-alpes.fr
• Study Contact Backup: Name: COUSIN EMILIE, PhD; Phone Number: 0033 0613638645; Email: emilie.cousin@univ-grenoble-alpes.fr

Study Locations

• France
  • La Tronche, France, 38700
    • Recruiting
    • Unité Mixte de Service IRMaGe US 017
    • Contact: COUSIN EMILIE, PhD; Phone Number: 0033 0613638645; Email: emilie.cousin@univ-grenoble-alpes.fr
    • Contact: TROPRES IRENE, PhD; Phone Number: 0033 4 76 76 93 08; Email: irene.tropres@univ-grenoble-alpes.fr
    • Principal Investigator: ATTYE ARNAUD, MD, PhD
    • Sub-Investigator: GRAND SYLVIE, MD, PhD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Diffusion Tensor Imaging Images	DTi sequences on IRM Achieva 3.0T dStream Philips	1 to 3 hours
BOLD Signal	EPI sequences during cognitive protocol on IRM Achieva 3.0T dStream Philips	1 to 3 Hours
Anatomical Images	Anatomical MR sequences on IRM Achieva 3.0T dStream Philips	1 to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye movements	Acquired by using eye-tracker (Eye-tracker Eyelink) breathing arteries pressure electrodermal conductance	During MRI session
Electrodermal resistance	Acquired on BIOPAC device allowing physiological measurements	During MRI session
Blood Pressure/pulse/Breathing	Acquired on INVIVO Precess	During MRI session
Near-infrared spectroscopy (NIRS) : Hb OHb concentration measurement	Acquired with NIRS Oxymon artinis medical system	During MRI session
tES	Transcranial Electrical stimulation, Neuroelectrics	During MRI session

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Estimated): September 8, 2026
• Study Completion (Estimated): September 8, 2026

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID 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