SchizophreniaNCT04300946
Time Prediction and Cerebellum: Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers
An observational study of Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- TMS targeted on the cerebellum
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2021to 1 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers
Who may be able to join
- 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
Who cannot join
- - 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)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Schizophrenia
- Being tested
- TMS targeted on the cerebellum
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMS targeted on the cerebellumDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| TMS on the cerebellum followed by placebo TMS | TMS preceding the time prediction and language tests Receives: Device: TMS targeted on the cerebellum | |
| Placebo TMS followed by TMS on the cerebellum | TMS preceding the time prediction and language tests Receives: Device: TMS targeted on the cerebellum | |
| TMS on the cerebellum set in time on waiting periods | Not described Receives: Device: TMS targeted on the cerebellum | |
| TMS on the cerebellum not set in time on waiting periods | Not described Receives: Device: TMS targeted on the cerebellum |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG index of time expectation
CNV
Measured: 40 minutes
EEG index of time expectation
beta oscillation
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start10 Oct 2021
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300946
- Sponsor's protocol ID
- 7650
- Status last verified
- Aug 2025
- First submitted
- 5 Mar 2020
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Magnetic Transcranial Stimulation (TMS) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04300946
- Acronym / sponsor ID
- 7650
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TMS on the cerebellum followed by placebo TMS | – | Device: TMS targeted on the cerebellumTMS preceding the time prediction and language tests |
| Placebo TMS followed by TMS on the cerebellum | – | Device: TMS targeted on the cerebellumTMS preceding the time prediction and language tests |
| TMS on the cerebellum set in time on waiting periods | – | Device: TMS targeted on the cerebellum |
| TMS on the cerebellum not set in time on waiting periods | – | Device: TMS targeted on the cerebellum |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMS targeted on the cerebellumImpact 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. | Device | Placebo TMS followed by TMS on the cerebellum, TMS on the cerebellum followed by placebo TMS, TMS on the cerebellum not set in time on waiting periods, TMS on the cerebellum set in time on waiting periods |
Primary outcome
EEG index of time expectation
Time frame: 40 minutes
CNV
EEG index of time expectation
Time frame: 40 minutes
beta oscillation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Giersch (000333 ext. 88 11 64 71, giersch@unistra.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG index of time expectation (time frame: 40 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.