Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT07453108
Active, not recruiting Not applicable

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

NCT07453108 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Not applicable
Started
2023-05-17
Last updated
2026-03-05

Condition(s) studied

Neuropsychiatric Disorders

Investigational drug(s) / intervention(s)

MRI (Magnetic Resonance Imaging)TMS (Transcranial Magnetic Stimulation)MRI (Magnetic Resonance Imaging)

MRI (Magnetic Resonance Imaging): 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.

TMS (Transcranial Magnetic Stimulation): 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

MRI (Magnetic Resonance Imaging): 2 MRI sessions on 3 Tesla Vida scanner at V3, separated by minimum one week. 2 MRI sessions on "new" MR-scanner 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
86 Years
Healthy volunteers
Accepted
Inclusion Criteria: * 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 * Woman of childbearing age: negative urine pregnancy test at the inclusion visit and effective contraception throughout the study (intrauterine device, sterilisation, oestrogen or progestin per os, injectable or as an implant or ring). Exclusion Criteria: * 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); * History of potentially affecting brain function (general anaesthesia or Electroconvulsive Therapy (ECT) \< 3 months prior to inclusion); * 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) ; * Exclusion period (determined by a previous or current study).

Primary outcome measure(s)

  • Recalibration of MRI database — From enrollment to the end of participation at 39.5 months maximum
    Number of subjects for whom complete and sufficient high-quality data have been collected
  • Physiological parameters — From enrollment to the end of participation at 39.5 months maximum
    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.

Trial sites (1)

FacilityCityRegionStatus
Les Hôpitaux Universitaires Strasbourg Bas-Rhin

More University Hospital, Strasbourg, France trials in France

The Interest of Systematic Screening for Dengue, Chikungunya, and Zika, in Malaria-negative Return Travelers Active, not recruiting
Dynamical Electrophysiology and Neuropathology in Lewy's Bodies Disease Recruiting
Impact of Perioperative Organ Resuscitation of Brain-dead Deceased Organ Donor on Kidney Graft Function in the Recipient Recruiting
Description of a Retrospective Cohort of Patients With Transthyretin Cardiac Amyloidosis (ATTR-CA) in Internal Medicine Recruiting
Study of the Care Pathway of Patients Admitted to the Palliative Care Unit of Strasbourg University Hospital From Their Home in 2025 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07453108 on ClinicalTrials.gov ↗ ← All trials in France