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| Name | Class |
|---|---|
| ICube Laboratory | UNKNOWN |
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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:
This is a randomized, double-blind study involving 40 healthy volunteers. Participants will be split into two groups:
Each participant will attend three different test sessions in a random order:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory | Experimental | Participants receive active rTMS to Lobule VIII in the first session, followed by active rTMS to Crus I/II in the second, and Sham stimulation in the third. |
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| 2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory | Experimental | Participants receive active rTMS to Lobule VIII, followed by Sham stimulation, and finally active rTMS to Crus I/II. |
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| 3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory | Experimental | Participants receive active rTMS to Crus I/II, followed by active rTMS to Lobule VIII, and finally Sham stimulation. |
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| 4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory | Experimental | Participants receive active rTMS to Crus I/II, followed by Sham stimulation, and finally active rTMS to Lobule VIII. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active rTMS - Lobule VIII | Device | Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Pre-stimulation) and 1-hour post-stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne GIERSCH | Contact | +33(0)3 88 11 64 71 | +33 | giersch@unistra.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpitaux Universitaires de Strasbourg | Strasbourg | 67091 | France |
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Only the personnel specifically operating the rTMS platform will have knowledge of the type of stimulation (active target VIII, active target Crus I/II, or Sham) being administered to each participant. This ensures that both the volunteer and the research team evaluating the behavioral and imaging data remain unaware of the intervention assignment until the end of the analysis phase.
| 5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory | Experimental | Participants receive Sham stimulation first, followed by active rTMS to Lobule VIII and active rTMS to Crus I/II. |
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| 6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory | Experimental | Participants receive Sham stimulation first, followed by active rTMS to Crus I/II and active rTMS to Lobule VIII |
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| 1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory | Experimental |
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| 2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory | Experimental |
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| 3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory | Experimental |
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| 4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory | Experimental |
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| 5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory | Experimental |
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| 6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory | Experimental |
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| Active rTMS - Crus I/II | Device | Participants 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. |
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| Sham rTMS | Device | The 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. |
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| Cognitive and Motor Assessment Battery | Behavioral | Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
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