Time Prediction and Cerebellum: Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers

Effects of the Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers

The aim of the study is to check the role of the cerebellum in time prediction in healthy volunteers, by means of magnetic transcranial stimulation targeted on the cerebellum, and recording of behavioural measures indexing time prediction

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Device: TMS targeted on the cerebellum

• Study Type: Observational
• Enrollment (Estimated): 48

Contacts and Locations

• Study Contact: Name: Anne Giersch; Phone Number: 88 11 64 71 000333; Email: giersch@unistra.fr

Study Locations

• France
  • Strasbourg, France
    • Recruiting
    • CHU Strasbourg
    • Contact: Anne Giersch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers

Description

Inclusion Criteria:

• Participant, male or female, between 18 and 60 years old
• Subject affiliated to a social health insurance scheme (beneficiary or entitled person)
• Subject who has dated and signed an informed consent form
• For a woman of childbearing age, negative pregnancy test and effective contraception throughout the study

Exclusion Criteria:

• - Participant with substance use disorders (as defined by DSM-V)
• Participants taking benzodiazepines and related substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product), cannabis (in the 2 months before inclusion) or hallucinogenic substances (in the period before inclusion, for a duration equivalent to 5 half-lives of the product).
• Participant with neurological pathology or sequelae
• Participant with Attention Deficit Hyperactivity Disorder (ADHD)
• Participant with a borderline personality disorder
• Participant with disabling sensory impairments, including visual acuity (corrected, if applicable) < 0.8 (due to use of visual material) (Freiburg Vision Test, Bach 1996)
• Participant deprived of liberty or subject to the safeguard of justice
• Participant under guardianship or curatorship
• Participant in a period of exclusion defined by another clinical study or participant in a study that may impact on research results
• Pregnant or breastfeeding woman
• Subject with a contraindication to performing an MRI or TMS: presence of non-removable ferromagnetic body, prosthesis, pacemaker, medication delivered by an implanted pump, vascular clip or stent, heart valve or ventricular lead, certain intracerebral clips, cochlear implants, history of epilepsy, skin pathology at the point of contact with the electrodes.
• Subject with a history of major neurological or psychiatric illness with current psychotropic medication (i.e., antidepressant, thyroid regulator, antipsychotic, benzodiazepine and related drugs, or hypnotic).

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TMS on the cerebellum followed by placebo TMS; TMS preceding the time prediction and language tests	Device: TMS targeted on the cerebellum; Impact on EEG performance (preparation wave in temporal tasks) of cerebellar stimulation by MSD in healthy subjects. The contrast between the post-stimulation effects of verrum stimulation and placebo stimulation will indicate the magnitude of the effect and will allow us to optimize the type of protocol that may be useful in schizophrenia.
Placebo TMS followed by TMS on the cerebellum; TMS preceding the time prediction and language tests	Device: TMS targeted on the cerebellum; Impact on EEG performance (preparation wave in temporal tasks) of cerebellar stimulation by MSD in healthy subjects. The contrast between the post-stimulation effects of verrum stimulation and placebo stimulation will indicate the magnitude of the effect and will allow us to optimize the type of protocol that may be useful in schizophrenia.
TMS on the cerebellum set in time on waiting periods	Device: TMS targeted on the cerebellum; Impact on EEG performance (preparation wave in temporal tasks) of cerebellar stimulation by MSD in healthy subjects. The contrast between the post-stimulation effects of verrum stimulation and placebo stimulation will indicate the magnitude of the effect and will allow us to optimize the type of protocol that may be useful in schizophrenia.
TMS on the cerebellum not set in time on waiting periods	Device: TMS targeted on the cerebellum; Impact on EEG performance (preparation wave in temporal tasks) of cerebellar stimulation by MSD in healthy subjects. The contrast between the post-stimulation effects of verrum stimulation and placebo stimulation will indicate the magnitude of the effect and will allow us to optimize the type of protocol that may be useful in schizophrenia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG index of time expectation	CNV	40 minutes
EEG index of time expectation	beta oscillation	40 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2021
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 9, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: 7650 (CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No