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Recruiting NCT05036629

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

No phase Interventional MRI Sequence Optimization Physiological Measurement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI Protocol.
Who it may be relevant to
Registry conditions: MRI, Sequence Optimization, Physiological Measurement. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

  • 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)

Primary outcome measures

  • Diffusion Tensor Imaging Images [Time frame: 1 to 3 hours]
  • BOLD Signal [Time frame: 1 to 3 Hours]
  • Anatomical Images [Time frame: 1 to 3 hours]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Unité Mixte de Service IRMaGe US 017 — La Tronche

Identifiers

NCT: NCT05036629 · 38RC20.395 · 2020-A03555-34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗