Reference Measurements of the Neuronal Integration Window and Anatomical and Functional MRI (Magnetic Resonance Imaging)

NCT07453108 | Active Not Recruiting

• 1 other identifier: 8890
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Our studies on MRI (Magnetic resonance imaging) biomarkers in neuropsychiatric disorders rely on reference data from control subjects which are dependent from our scanner. Due to the upcoming replacement of our MR scanner, the investigators need to 'recalibrate' our current database by acquiring the same data on both the old and the new device from a small group of controls (n = 36 to 40). This will be combined with measures of cortical excitability using robotized TMS (transcranial magnetic stimulation) that will be combined to MRI biomarkers in forthcoming studies. Therefore, the primary objective of this biomedical trial is to collect MRI and physiological measurements in normal subjects whose characteristics match to our study populations.

Conditions

Neuropsychiatric Disorders

Keywords

MRI (Magnetic Resonance Imaging System); TMS (transcranial magnetic stimulation)

Outcome Measures

Primary Outcomes (2)

• Recalibration of MRI database

  Number of subjects for whom complete and sufficient high-quality data have been collected

  From enrollment to the end of participation at 39.5 months maximum

• Physiological parameters

  Reproduction of results for motor mapping of the motor evoked potential (MEP) - both passive and active - and of the silent period, as well as estimation of the distribution functions for the various measurements.

  From enrollment to the end of participation at 39.5 months maximum

Secondary Outcomes (1)

• Incidence of adverse events (AEs) during the various procedures

  From enrollment to the end of participation at 39.5 months maximum

Study Arms (1)

Healthy subjects

OTHER

Healthy subjects

Other: MRI (Magnetic Resonance Imaging); Other: TMS (Transcranial Magnetic Stimulation)

Interventions

MRI (Magnetic Resonance Imaging) OTHER

2 MRI sessions on 3 Tesla Vério Siemens scanner at V1, separated by minimum one week Anatomical and functional measures: * 3 ASL-fMRI with ET = 9.7 ms, 3 ASL-fMRI with ET = 21 ms during various tasks. * Multiparametric quantitative measures (NODDI, R1, R2, R2\*, magnetic susceptibility, macromolecular proton fraction). * 3DT1 and 3D FLAIR.

Healthy subjects

TMS (Transcranial Magnetic Stimulation) OTHER

1 session at visit V2. Intracortical inhibition, neuronal integration and window of simultaneity Mapping of passive and active motor evoked potential MEP using dedicated robotic device under the control of neuronavigation. + cortical and trans-cortical silence period

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 86 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women aged 18 to 86 inclusive;
• Affiliated to a social health insurance scheme
• Able to understand the objectives and risks of the research and to give dated and signed informed consent;
• B2 or above level of French language according to the European Framework of Reference for Languages;
• No personal or family psychiatric history of endogenous psychosis, including substance abuse (excluding moderate tobacco, alcohol and caffeine use);
• No chronic pathology requiring treatment (mainly diabetes, hypertension, hyperlipidemia or cholesterolemia);
• Matched on age, gender and education level of the patients included in our different studies

You may not qualify if:

• Contraindication to MRI or rTMS: presence of a non-removable ferromagnetic foreign body, prosthesis, pacemaker, medication delivered by an implanted pump, vascular clip or stent, heart valve or ventricular bypass, epilepsy;
• History that may affect brain anatomy or be related to an abnormality (neurosurgery, epilepsy, stroke, head injury with loss of consciousness for more than 15 minutes and mental retardation - Intelligence Quotient (IQ) \< 70 on the fNART);
• Breastfeeding women ;
• Pregnant women ;
• Serious or unstabilised somatic pathology ;
• Chronic intake of a treatment related to an ongoing disease;
• Deprived of liberty, in forced care or under legal protection ;
• Under guardianship or curatorship ;
• Emergency or life-threatening situation) ;

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires

Strasbourg, Bas-Rhin, 67091, France

Location

MeSH Terms

Interventions

Magnetic Resonance Spectroscopy; Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Magnetic Field Therapy; Therapeutics

Study Officials

• Jack FOUCHER

  CEntre de neuroModulation Non-Invasive de Strasbourg (CEMNIS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Healthy subjects: maximum of 40 inclusions to have at least 36 usable results.

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: March 5, 2026
• Study Start: May 17, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)