NCT05036629

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2021Sep 2026

First Submitted

Initial submission to the registry

August 24, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

September 9, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2026

Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

5 years

First QC Date

August 24, 2021

Last Update Submit

October 17, 2023

Conditions

MRISequence OptimizationPhysiological Measurement

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Eye movements

    During MRI session

  • Electrodermal resistance

    During MRI session

  • Blood Pressure/pulse/Breathing

    During MRI session

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

    During MRI session

  • tES

    During MRI session

Study Arms (1)

MRI protocol

EXPERIMENTAL

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

Interventions

MRI ProtocolDEVICE

Eye-tracker Eyelink (eye movements) BIOPAC : (electrodermal resistance) INVIVO Precess : breathing, arterial pressure, pulse, * NIRS Oxymon artinis medical system * tES (transcranial electrical stimulation, Neuroelectrics)

Also known as: Physiological measurement during MRI protocol
MRI protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unité Mixte de Service IRMaGe US 017

La Tronche, 38700, France

RECRUITING

Central Study Contacts

ATTYE ARNAUD, MD, PhD

CONTACT

4 76 76 57 39aattye@chu-grenoble-alpes.fr

COUSIN EMILIE, PhD

CONTACT

0613638645emilie.cousin@univ-grenoble-alpes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Exploratory individual statistical analyzes on MRI data functional. No group analysis possible on these updates of MRI protocols
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

September 5, 2021

Study Start

September 9, 2021

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

September 8, 2026

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)