Effects of Repetitive Transcranial Magnetic Stimulation on Two Cerebellar Targets (StimCervelet)
27 de abril de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Anne GIERSCH
- Número de teléfono: +33 +33(0)3 88 11 64 71
- Correo electrónico: giersch@unistra.fr
Ubicaciones de estudio
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-
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Strasbourg, Francia, 67091
- Hopitaux Universitaires de Strasbourg
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Contacto:
- Anne GIERSCH
- Número de teléfono: +33 +33(0)3 88 11 64 71
- Correo electrónico: giersch@unistra.fr
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
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)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
|
Experimental: 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.
Otros nombres:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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.
Periodo de tiempo: 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.
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Baseline (Pre-stimulation) and 1-hour post-stimulation
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
2 de enero de 2030
Finalización del estudio (Estimado)
2 de enero de 2030
Fechas de registro del estudio
Enviado por primera vez
17 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- RC26_0179
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .