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

MRI Clinical Trial

— MAP-IRMaGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05036629
• Other study ID #: 38RC20.395
• Secondary ID: 2020-A03555-34
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: September 8, 2026

Study information

• Verified date: October 2023
• Source: University Hospital, Grenoble
• Contact: ATTYE ARNAUD, MD, PhD
• Phone: 4 76 76 57 39
• Email: aattye[@]chu-grenoble-alpes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 8, 2026
• Est. primary completion date: September 8, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• MRI
• Sequence Optimization

Intervention

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)

Locations

Country	Name	City	State
France	Unité Mixte de Service IRMaGe US 017	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diffusion Tensor Imaging Images	DTi sequences on IRM Achieva 3.0T dStream Philips	1 to 3 hours
Primary	BOLD Signal	EPI sequences during cognitive protocol on IRM Achieva 3.0T dStream Philips	1 to 3 Hours
Primary	Anatomical Images	Anatomical MR sequences on IRM Achieva 3.0T dStream Philips	1 to 3 hours
Secondary	Eye movements	Acquired by using eye-tracker (Eye-tracker Eyelink) breathing arteries pressure electrodermal conductance	During MRI session
Secondary	Electrodermal resistance	Acquired on BIOPAC device allowing physiological measurements	During MRI session
Secondary	Blood Pressure/pulse/Breathing	Acquired on INVIVO Precess	During MRI session
Secondary	Near-infrared spectroscopy (NIRS) : Hb OHb concentration measurement	Acquired with NIRS Oxymon artinis medical system	During MRI session
Secondary	tES	Transcranial Electrical stimulation, Neuroelectrics	During MRI session