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

NCT ID: NCT05036629

Last Updated: 2023-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-09

Study Completion Date

2026-09-08

Brief Summary

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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

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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

Conditions

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MRI Sequence Optimization Physiological Measurement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Exploratory individual statistical analyzes on MRI data functional. No group analysis possible on these updates of MRI protocols
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

MRI Protocol

Intervention Type 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)

Interventions

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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)

Intervention Type DEVICE

Other Intervention Names

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Physiological measurement during MRI protocol

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Unité Mixte de Service IRMaGe US 017

La Tronche, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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ATTYE ARNAUD, MD, PhD

Role: CONTACT

4 76 76 57 39 ext. 0033

COUSIN EMILIE, PhD

Role: CONTACT

0613638645 ext. 0033

Facility Contacts

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COUSIN EMILIE, PhD

Role: primary

0613638645 ext. 0033

TROPRES IRENE, PhD

Role: backup

4 76 76 93 08 ext. 0033

Other Identifiers

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2020-A03555-34

Identifier Type: OTHER

Identifier Source: secondary_id

38RC20.395

Identifier Type: -

Identifier Source: org_study_id

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