Effects of Repetitive Transcranial Magnetic Stimulation on Two Cerebellar Targets
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity Hospital, Strasbourg, France
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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Active rTMS - Lobule VIII
DeviceEither excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
Active rTMS - Crus I/II
DeviceParticipants receive rTMS targeting the Crus I/II of the cerebellum. Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
Sham rTMS
DeviceThe coil looks and sounds identical to the active coil and is placed in the same positions (counterbalanced between Lobule VIII and Crus I/II sites). It provides the physical sensation and auditory "click" of TMS without delivering a significant magnetic field to the brain tissue, maintaining the study's double-blind integrity.
Cognitive and Motor Assessment Battery
BehavioralParticipants perform three computerized tasks to evaluate the functional impact of the rTMS: * Visuomotor Task: A joystick-based task assessing motor coordination and learning (linked to Lobule VIII). * Temporal Prediction Task: A visual task requiring the participant to predict the timing of an event (linked to Crus I/II). * Mental Imagery \& Finger Tapping: A task assessing the cognitive representation of movement.
Treatment groups
40 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: 1 - Lobule VIII - Crus I/II - Sham Sequence - ExcitatoryExperimental treatment 4 interventions
Group B: 2 - Lobule VIII - Sham - Crus I/II Sequence - ExcitatoryExperimental treatment 4 interventions
Group C: 3 - Crus I/II - Lobule VIII - Sham Sequence - ExcitatoryExperimental treatment 4 interventions
Group D: 4 - Crus I/II - Sham - Lobule VIII Sequence - ExcitatoryExperimental treatment 4 interventions
Group E: 5 - Sham - Lobule VIII - Crus I/II Sequence - ExcitatoryExperimental treatment 4 interventions
Group F: 6 - Sham - Crus I/II - Lobule VIII Sequence - ExcitatoryExperimental treatment 4 interventions
Group G: 1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitoryExperimental treatment 4 interventions
Group H: 2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitoryExperimental treatment 4 interventions
Group I: 3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitoryExperimental treatment 4 interventions
Group J: 4 - Crus I/II - Sham - Lobule VIII Sequence - InhibitoryExperimental treatment 4 interventions
Group K: 5 - Sham - Lobule VIII - Crus I/II Sequence - InhibitoryExperimental treatment 4 interventions
Group L: 6 - Sham - Crus I/II - Lobule VIII Sequence - InhibitoryExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Change in Resting-State Functional Connectivity (RSFC) Measured by functional Magnetic Resonance Imaging (fMRI, expressed as Fisher's z-transformed correlation coefficients) within Cerebellar-Thalamo-Frontal and Cerebellar-Parieto-Motor Networks.
Functional imaging data will be pre-processed according to standard procedures: slice-timing correction, intra-run spatial realignement, inter-run realignement, distortion and motion artifact correction, band-pass filtering to remove physiological noise, and normalization into the MNI common space, followed by smoothing using FSL and SPM12 software.Subsequently, the signal within the networks of interest will be extracted using the "Conn" toolbox and compared using a General Linear Model (GLM). Connectivity maps will be generated from specific "seed" regions of interest (Crus I/II and lobule VIII), where each voxel value corresponds to the correlation with the seed region.
Time frame
Baseline (Pre-stimulation) and 1-hour post-stimulationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Strasbourg, France
Lead sponsor
ICube Laboratory
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: