Tourette Syndrome in AdolescenceCADETSNCT04179435
Cognitive and Brain Development in Adolescents With Gilles de la Tourette Syndrome
A study testing Behavioral testing on cognitive computerized tasks, brain MRI and TMS in people with Tourette Syndrome in Adolescence, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
In children with neurodevelopmental disorders, adolescence is usually associated with a reshaping of the clinical picture and symptomatology. Tourette syndrome (TS) is a paradigmal neurodevelopmental syndrome characterised by involuntary paroxysmal movements (motor tics) and vocalisation (vocal tics) often associated… Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome in Adolescence
- What is being tested?
- Behavioral testing on cognitive computerized tasks, brain MRI and TMS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2019to 18 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Tourette syndrome
- Ages 13 - 18
- Acceptance to perform the Brain MRI
- Acceptance to perform the cognitive testing
- Acceptance to perform the TMS measures
Who cannot join
- Learning disability
- Incompatibility with MRI procedure (metal body implants, pregnancy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Développement Cognitif et cérébral Chez Les Adolescents Souffrants d'un Syndrome de Gilles de la Tourette
In children with neurodevelopmental disorders, adolescence is usually associated with a reshaping of the clinical picture and symptomatology. Tourette syndrome (TS) is a paradigmal neurodevelopmental syndrome characterised by involuntary paroxysmal movements (motor tics) and vocalisation (vocal tics) often associated with various psychiatric disorders. The neuronal and cognitive mechanisms associated with TS symptoms improvement during adolescence, or the persistence in adulthood remains unknown, and this is what we aim to address in this study.
Read the detailed description
Thus, the aims of the present project is threefold:
Aim 1: To evaluate the maturation of cognitive functions in adolescents with TS compared to typically developing adolescents.
To achieve this aim, three distinct cognitive dimensions will be assessed in all subjects (patients and controls): (i) reward sensitivity and habit formation; (ii) cognitive impulsivity and action control and (iii) self-agency.
Aim 2: To identify neuronal correlates of cognitive function and brain development in health and disease. To achieve this aim, we will use a combined behavioural (as described in Aim 1), (i) neuroimaging and (ii) TMS approaches.
Aim 3: To predict clinical outcome . In this part of the project we aim to identify behavioural, imaging or neurophysiological markers of clinical outcome in patients with TS.
- Conditions
- Tourette Syndrome in Adolescence
- Being tested
- Behavioral testing on cognitive computerized tasks, brain MRI, TMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral testing on cognitive computerized tasksBehavioural
Testing on cognitive computerized tasks
brain MRIOther
Brain MRI scans
TMSOther
Measure of the cortical inhibitory capacity using TMS measures
| Study group | Role | What they receive |
|---|---|---|
| Tourette syndrome | Other | Patients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures Receives: Behavioral: Behavioral testing on cognitive computerized tasks; Other: brain MRI; Other: TMS |
| Controls | Other | Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures Receives: Behavioral: Behavioral testing on cognitive computerized tasks; Other: brain MRI; Other: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral test main outcome measures [1]
reaction times
Measured: from 16 to 20 months
Behavioral test main outcome measures [2]
discounting factor
Measured: from 16 to 20 months
Behavioral test main outcome measures [3]
number of premature responses
Measured: from 16 to 20 months
Behavioral test main outcome measures [4]
agency composite scores
Measured: from 16 to 20 months
Brain MRI scan measures
whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology
Measured: from 16 to 20 months
Transcranial magnetic stimulation
Short Intracortical Inhibition (SICI) scores
Measured: from 16 to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start11 Dec 2019
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tourette Syndrome in AdolescenceStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Between group comparison
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Worbe Yulia, MD, PhD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179435
- Sponsor's protocol ID
- C19-11
- Other IDs
- 2019-A00992-55
- Acronym
- CADETS
- Status last verified
- Jun 2026
- First submitted
- 20 Nov 2019
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atkinson-Clement C, Duflot M, Lastennet E, Patsalides L, Wasserman E, Sartoris TM, Tarrano C, Rosso C, Burbaud P, Deniau E, Czernecki V, Roze E, Hartmann A, Worbe Y. How does Tourette syndrome impact adolescents' daily living? A text mining study. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2623-2635. doi: 10.1007/s00787-022-02116-1. Epub 2022 Dec 2.
PubMed 36460852
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Développement Cognitif et cérébral Chez Les Adolescents Souffrants d'un Syndrome de Gilles de la Tourette
- ClinicalTrials.gov ID
- NCT04179435
- Acronym / sponsor ID
- CADETS / C19-11
- Conditions
- Tourette Syndrome in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 11 Dec 2019 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 27 Nov 2019 (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.
In children with neurodevelopmental disorders, adolescence is usually associated with a reshaping of the clinical picture and symptomatology. Tourette syndrome (TS) is a paradigmal neurodevelopmental syndrome characterised by involuntary paroxysmal movements (motor tics) and vocalisation (vocal tics) often associated with various psychiatric disorders. The neuronal and cognitive mechanisms associated with TS symptoms improvement during adolescence, or the persistence in adulthood remains unknown, and this is what we aim to address in this study.
Detailed description
Thus, the aims of the present project is threefold:
Aim 1: To evaluate the maturation of cognitive functions in adolescents with TS compared to typically developing adolescents.
To achieve this aim, three distinct cognitive dimensions will be assessed in all subjects (patients and controls): (i) reward sensitivity and habit formation; (ii) cognitive impulsivity and action control and (iii) self-agency.
Aim 2: To identify neuronal correlates of cognitive function and brain development in health and disease. To achieve this aim, we will use a combined behavioural (as described in Aim 1), (i) neuroimaging and (ii) TMS approaches.
Aim 3: To predict clinical outcome . In this part of the project we aim to identify behavioural, imaging or neurophysiological markers of clinical outcome in patients with TS.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Between group comparison
| Arm | Type | Receives |
|---|---|---|
| Tourette syndrome | Other | Behavioral: Behavioral testing on cognitive computerized tasks, Other: brain MRI, Other: TMSPatients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures |
| Controls | Other | Behavioral: Behavioral testing on cognitive computerized tasks, Other: brain MRI, Other: TMSControls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Tourette syndrome
- Ages 13 - 18
- Acceptance to perform the Brain MRI
- Acceptance to perform the cognitive testing
- Acceptance to perform the TMS measures
Key exclusion criteria (2 listed)
- Learning disability
- Incompatibility with MRI procedure (metal body implants, pregnancy)
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 |
|---|---|---|
| Behavioral testing on cognitive computerized tasksTesting on cognitive computerized tasks | Behavioural | Controls, Tourette syndrome |
| brain MRIBrain MRI scans | Other | Controls, Tourette syndrome |
| TMSMeasure of the cortical inhibitory capacity using TMS measures | Other | Controls, Tourette syndrome |
Primary outcome
Behavioral test main outcome measures [1]
Time frame: from 16 to 20 months
reaction times
Behavioral test main outcome measures [2]
Time frame: from 16 to 20 months
discounting factor
Behavioral test main outcome measures [3]
Time frame: from 16 to 20 months
number of premature responses
Behavioral test main outcome measures [4]
Time frame: from 16 to 20 months
agency composite scores
Brain MRI scan measures
Time frame: from 16 to 20 months
whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology
Transcranial magnetic stimulation
Time frame: from 16 to 20 months
Short Intracortical Inhibition (SICI) scores
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Results publication: PubMed 36460852Atkinson-Clement C, Duflot M, Lastennet E, Patsalides L, Wasserman E, Sartoris TM, Tarrano C, Rosso C, Burbaud P, Deniau E, Czernecki V, Roze E, Hartmann A, Worbe Y. How does Tourette syndrome impact adolescents' daily living? A text mining study. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2623-2635. doi: 10.1007/s00787-022-02116-1. Epub 2022 Dec 2.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Worbe Yulia, MD, PhD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral testing on cognitive computerized tasks, brain MRI and TMS in people with Tourette Syndrome in Adolescence, run by Institut National de la Santé Et de la Recherche Médicale, 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 5 inclusion and 2 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: finished, as of the sponsor's last update on 18 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral test main outcome measures [1] (time frame: from 16 to 20 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04179435, which also lists 1 linked publication.
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 18 Sep 2026.