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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04300946
• Other study ID #: 7650
• Status: Recruiting
• Start date: October 10, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: Anne Giersch
• Phone: 000333
• Email: giersch[@]unistra.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
France	CHU Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG index of time expectation	CNV	40 minutes
Primary	EEG index of time expectation	beta oscillation	40 minutes