Effects of Repetitive Transcranial Magnetic Stimulation on Two Cerebellar Targets (StimCervelet)
27 april 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Studietype
Ingrijpend
Inschrijving (Geschat)
40
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Anne GIERSCH
- Telefoonnummer: +33 +33(0)3 88 11 64 71
- E-mail: giersch@unistra.fr
Studie Locaties
-
-
-
Strasbourg, Frankrijk, 67091
- Hopitaux Universitaires de Strasbourg
-
Contact:
- Anne GIERSCH
- Telefoonnummer: +33 +33(0)3 88 11 64 71
- E-mail: giersch@unistra.fr
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Ja
Beschrijving
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)
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Fundamentele wetenschap
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimenteel: 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.
Andere namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
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.
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Medewerkers
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 september 2026
Primaire voltooiing (Geschat)
2 januari 2030
Studie voltooiing (Geschat)
2 januari 2030
Studieregistratiedata
Eerst ingediend
17 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
27 april 2026
Eerst geplaatst (Werkelijk)
1 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
27 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- RC26_0179
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .