Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05036629

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unité Mixte de Service IRMaGe US 017

La Tronche, 38700, France

Location status: Recruiting

Location contact

ATTYE ARNAUD, MD, PhD

PRINCIPAL_INVESTIGATOR

COUSIN EMILIE, PhD

CONTACT

[email protected]

0613638645 ext. 0033

GRAND SYLVIE, MD, PhD

SUB_INVESTIGATOR

TROPRES IRENE, PhD

CONTACT

[email protected]

4 76 76 93 08 ext. 0033

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI Protocol

Device

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

Primary outcomes

  1. Diffusion Tensor Imaging Images

    Time frame: 1 to 3 hours

    DTi sequences on IRM Achieva 3.0T dStream Philips

  2. BOLD Signal

    Time frame: 1 to 3 Hours

    EPI sequences during cognitive protocol on IRM Achieva 3.0T dStream Philips

  3. Anatomical Images

    Time frame: 1 to 3 hours

    Anatomical MR sequences on IRM Achieva 3.0T dStream Philips

Secondary outcomes

  1. Eye movements

    Time frame: During MRI session

    Acquired by using eye-tracker (Eye-tracker Eyelink) breathing arteries pressure electrodermal conductance

  2. Electrodermal resistance

    Time frame: During MRI session

    Acquired on BIOPAC device allowing physiological measurements

  3. Blood Pressure/pulse/Breathing

    Time frame: During MRI session

    Acquired on INVIVO Precess

  4. Near-infrared spectroscopy (NIRS) : Hb OHb concentration measurement

    Time frame: During MRI session

    Acquired with NIRS Oxymon artinis medical system

  5. tES

    Time frame: During MRI session

    Transcranial Electrical stimulation, Neuroelectrics

Study contacts

Contact information is provided by the study sponsor or research team.

ATTYE ARNAUD, MD, PhD

CONTACT

[email protected]

4 76 76 57 39 ext. 0033

COUSIN EMILIE, PhD

CONTACT

[email protected]

0613638645 ext. 0033

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: MAP-IRMaGE

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Sep 5, 2021
Registry last updated
Oct 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.