About this trial
The purpose of this study is to understand how different areas of the cerebellum (a part of the brain) control different functions and how they can be influenced by non-invasive brain stimulation.
While researchers know that repetitive Transcranial Magnetic Stimulation (rTMS) can have positive effects on conditions like stroke and schizophrenia, they do not yet fully understand which specific stimulation settings work best or which exact parts of the cerebellum should be targeted for different symptoms.
This study compares the effects of stimulation on two specific regions:
* Lobule VIII: Linked to movement and motor learning. * CRUS I/II: Linked to attention, thinking (cognition), and predicting the timing of events.By comparing these areas, researchers hope to gain the information needed to develop better treatments for neurological and psychiatric disorders.
This is a randomized, double-blind study involving 40 healthy volunteers. Participants will be split into two groups:
* Group 1: Receives "exciting" (activity-increasing) stimulation. * Group 2: Receives "inhibiting" (activity-decreasing) stimulation.
Each participant will attend three different test sessions in a random order:
* rTMS targeting Lobule VIII * rTMS targeting CRUS I/II * Placebo (Sham) stimulation that looks and feels like the real thing but does not affect the brain.
During each session, researchers will use brain imaging (fMRI) and computerized tasks to measure changes in brain connectivity and performance in motor and cognitive activities.
There is no direct medical benefit to the participants. However, the results will help scientists create better therapies for patients with brain-related health issues The risks are considered minimal. Common side effects of rTMS include temporary mild headaches or a clicking sound during stimulation. MRI scans can sometimes cause mild discomfort or a feeling of closed-in spaces (claustrophobia). Researchers have put safety measures in place, such as hearing protection and constant medical supervision during scans, to minimize these risks.
Eligibility criteria
Qualifiers
Subject, male or female, aged between 18 and 60 years inclusive
Subject affiliated with or a beneficiary of a social security health insurance scheme
Subject has dated and signed the informed consent form prior to the start of any trial-related procedures
For women of childbearing potential, a negative urinary pregnancy test and the use of effective contraception throughout the duration of the study
Disqualifiers
Subject with substance use disorders (as defined by the DSM-5)
Subject having taken benzodiazepines and related compounds (within the period preceding inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (within the 2 months preceding inclusion), or hallucinogenic substances (within the period preceding inclusion, for a duration equivalent to 5 half-lives of the product)
Subject suffering from a neurological pathology or sequelae
Subject with Attention-Deficit/Hyperactivity Disorder (ADHD)
Trial design
Treatments tested in this trial
- Active rTMS - Lobule VIII
- Active rTMS - Crus I/II
- Sham rTMS
- Cognitive and Motor Assessment Battery
Treatment groups
12
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University Hospital, Strasbourg, France
Lead sponsor
ICube Laboratory
Collaborator