Reference Measurements of the Neuronal Integration Window and Anatomical and Functional MRI
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Recalibration of MRI database
Study Overview
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.
Detailed Description
An inclusion period of 4 months will allow for the inclusion of the necessary subjects.
Controls will be recruited through mailings, classified ads and/or posters, adapting age, gender and education criteria as the investigators go along to match investigators's target populations.
Making contact and appointments: During the telephone contact with the subject, the investigators provide the initial information concerning the objectives, the course and the constraints of the study. An appointment will be made after checking that the main eligibility criteria have been met.
Information and selection visit (min. 24 hours before V0): This visit can be carried out by web-conference or on one of the technical platforms (iCube laboratory).
After checking that the participant meets all the eligibility criteria, the investigator will repeat the information about the protocol and its constraints and answer the subject's questions. The patient will be offered a reflection period of at least 24 hours. If the patient accepts, an appointment will be made for the inclusion visit.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 86 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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).
Arms & Interventions
Healthy subjects
Healthy subjects
Intervention: MRI (Magnetic Resonance Imaging) (Other)
Healthy subjects
Healthy subjects
Intervention: TMS (Transcranial Magnetic Stimulation) (Other)
Outcomes
Primary Outcomes
Recalibration of MRI database
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- Incidence of adverse events (AEs) during the various procedures(From enrollment to the end of participation at 39.5 months maximum)