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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Recruiting

CT.gov ID

NCT04300946

Collaborator

(none)

Enrollment

Location

23.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Device: TMS targeted on the cerebellum

Study Design

Study Type:

Observational

Anticipated Enrollment :

48 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Oct 10, 2021

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

EEG index of time expectation [40 minutes]
CNV
EEG index of time expectation [40 minutes]
beta oscillation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Strasbourg	Strasbourg		France

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT04300946

Other Study ID Numbers:

7650

First Posted:

Mar 9, 2020

Last Update Posted:

Aug 19, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Aug 19, 2022