Development of MRI Protocols and Associated Neuro-physiological Explorations in Healthy and Pathological Subjects

Not Applicable

Recruiting

• Conditions: Sequence Optimization; Physiological Measurement; MRI
• Interventions: Device: MRI Protocol

• Registration Number: NCT05036629
• Lead Sponsor: University Hospital, Grenoble

Brief 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 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 Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-05
• Study Start: 2021-09-09
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-17
• Last Update Posted: 2023-10-18
• Primary Completion: 2026-09-08
• Study Completion: 2026-09-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI protocol	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Unité Mixte de Service IRMaGe US 017; 🇫🇷 La Tronche, France