Effects of Repetitive Transcranial Magnetic Stimulation on Two Cerebellar Targets (StimCervelet)
27. April 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Studientyp
Interventionell
Einschreibung (Geschätzt)
40
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Anne GIERSCH
- Telefonnummer: +33 +33(0)3 88 11 64 71
- E-Mail: giersch@unistra.fr
Studienorte
-
-
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Strasbourg, Frankreich, 67091
- Hôpitaux Universitaires de Strasbourg
-
Kontakt:
- Anne GIERSCH
- Telefonnummer: +33 +33(0)3 88 11 64 71
- E-Mail: giersch@unistra.fr
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
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.
Andere Namen:
Participants perform three computerized tasks to evaluate the functional impact of the rTMS:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
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.
Zeitfenster: 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
|
Mitarbeiter und Ermittler
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Mitarbeiter
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. September 2026
Primärer Abschluss (Geschätzt)
2. Januar 2030
Studienabschluss (Geschätzt)
2. Januar 2030
Studienanmeldedaten
Zuerst eingereicht
17. April 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. April 2026
Zuerst gepostet (Tatsächlich)
1. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
1. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. April 2026
Zuletzt verifiziert
1. April 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- RC26_0179
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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