Effects of Repetitive Transcranial Magnetic Stimulation on Two Cerebellar Targets (StimCervelet)
27 aprile 2026 aggiornato da: University Hospital, Strasbourg, France
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Two Cerebellar Targets (Lobule VIII vs. CRUS I/II)
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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Tipo di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Anne GIERSCH
- Numero di telefono: +33 +33(0)3 88 11 64 71
- Email: giersch@unistra.fr
Luoghi di studio
-
-
-
Strasbourg, Francia, 67091
- Hopitaux Universitaires de Strasbourg
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Contatto:
- Anne GIERSCH
- Numero di telefono: +33 +33(0)3 88 11 64 71
- Email: giersch@unistra.fr
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Sì
Descrizione
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Subject with Borderline Personality Disorder
- Subject presenting with disabling sensory impairments, specifically a visual acuity (corrected, if applicable) < 0.8 (due to the use of visual materials; Freiburg Vision Test, Bach 1996; verified during an examination at the screening visit)
- Subject deprived of liberty or under legal protection
- Subject under guardianship or trusteeship
- Pregnant or breastfeeding woman (verified by a urinary test at the screening visit)
- Subject within an exclusion period defined by another clinical study or participating in a study likely to impact the results of the research
- Subject presenting a contraindication for fMRI or rTMS: presence of non-removable ferromagnetic bodies, prostheses, pacemakers, implanted medication pumps, vascular clips or stents, heart valves or ventricular shunts, certain intracerebral clips, cochlear implants, history of seizures (epilepsy), or skin breach/pathology at the point of contact with the electrodes
- Subject with a history of major neurological or psychiatric disease with current psychotropic medication (i.e., antipsychotics, benzodiazepines and related compounds, or hypnotics)
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Scienza basilare
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 1 - Lobule VIII - Crus I/II - Sham Sequence - Excitatory
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.
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 2 - Lobule VIII - Sham - Crus I/II Sequence - Excitatory
Participants receive active rTMS to Lobule VIII, followed by Sham stimulation, and finally active rTMS to Crus I/II.
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 3 - Crus I/II - Lobule VIII - Sham Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by active rTMS to Lobule VIII, and finally Sham stimulation.
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 4 - Crus I/II - Sham - Lobule VIII Sequence - Excitatory
Participants receive active rTMS to Crus I/II, followed by Sham stimulation, and finally active rTMS to Lobule VIII.
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 5 - Sham - Lobule VIII - Crus I/II Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Lobule VIII and active rTMS to Crus I/II.
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 6 - Sham - Crus I/II - Lobule VIII Sequence - Excitatory
Participants receive Sham stimulation first, followed by active rTMS to Crus I/II and active rTMS to Lobule VIII
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 1 - Lobule VIII - Crus I/II - Sham Sequence - inhibitory
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 2 - Lobule VIII - Sham - Crus I/II Sequence - inhibitory
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 3 - Crus I/II - Lobule VIII - Sham Sequence - inhibitory
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 4 - Crus I/II - Sham - Lobule VIII Sequence - Inhibitory
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 5 - Sham - Lobule VIII - Crus I/II Sequence - Inhibitory
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Sperimentale: 6 - Sham - Crus I/II - Lobule VIII Sequence - Inhibitory
|
Either excitatory (e.g., iTBS) or inhibitory (e.g., cTBS) depending on the assigned group.
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.
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.
Altri nomi:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
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.
Lasso di tempo: Baseline (Pre-stimulation) and 1-hour post-stimulation
|
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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
2 gennaio 2030
Completamento dello studio (Stimato)
2 gennaio 2030
Date di iscrizione allo studio
Primo inviato
17 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
27 aprile 2026
Primo Inserito (Effettivo)
1 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
1 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- RC26_0179
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .