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

U

University Hospital, Strasbourg, France

Status

Enrolling

Conditions

Schizophrenia

Treatments

Device: TMS targeted on the cerebellum

Study type

Observational

Funder types

Other

Identifiers

NCT04300946
7650 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

48 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

48 participants in 4 patient groups

TMS on the cerebellum followed by placebo TMS
Description:
TMS preceding the time prediction and language tests
Treatment:
Device: TMS targeted on the cerebellum
Placebo TMS followed by TMS on the cerebellum
Description:
TMS preceding the time prediction and language tests
Treatment:
Device: TMS targeted on the cerebellum
TMS on the cerebellum set in time on waiting periods
Treatment:
Device: TMS targeted on the cerebellum
TMS on the cerebellum not set in time on waiting periods
Treatment:
Device: TMS targeted on the cerebellum

Trial contacts and locations

1

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Central trial contact

Anne Giersch

Data sourced from clinicaltrials.gov

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