Tourette SyndromeCOGITNCT02960698
Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study
A study testing IRM and comportemental tasks in people with Tourette Syndrome, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics. Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source of these troubles. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- IRM and comportemental tasks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2016to 24 Apr 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For all subjects:
- ≥ about 18 and 65 years old
- About receiving Social Security or universal health coverage or any equivalent plan
- About who signed the informed consent
- For TS patients treated :
- TS principal diagnosis, based on the DSM-5 criteria
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- Stable pharmacological treatment at least 4 weeks prior to study entry;
- Possibility of controlling the majority tics of the upper part of the body lying down for at least 10 minutes (frequency tics on YGTSS <3).
- For TS patients untreated:
- TS principal diagnosis, based on the DSM-5 criteria
- No psychotropic treatments (neuroleptics, antidepressants or anxiolytics) mentioned at the time of inclusion.
- Possibility of controlling the majority tics of the upper part of the body lying down for at least 10 minutes (frequency tics on YGTSS <3).
- In healthy volunteers:
- Normal neurological examination (evaluation MINI).
- No regular pharmacological treatment with the exception of birth control pills for women
Who cannot join
- For all patients TS:
- Age <18 years.
- Presence One of the following diagnoses Axis I DSM-5: schizophrenic disorders or current psychotic episode or in the past, bipolar disorder, current major depressive disorder autism spectrum.
- Abus Psychotropic substance dependency or a psychotropic substance, including alcohol (except nicotine).
- Support Regular / chronic drugs and other xenobiotics tropic psychotropic.
- Support Treatment with benzodiazepines in the 4 months prior to study entry. -Patient Subject to a measure of legal protection (guardianship, curatorship or safeguard justice). -No private freedom by administrative decision or justice.
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- No Unable to consent and are not subject to a protection measure.
- Participation In other biomedical research or subjected to an exclusion period for another search.
- Problems General understanding.
- Weight Of more than 150 kg.
- Inability To maintain an upper portion of movement of the body lying down for at least 10 minutes (frequency tics on YGTSS> 3).
- In healthy volunteers (HV):
- psychiatric disorders, cognitive impairment assessed by the MINI scale.
- About not being able to understand the tasks
- age <18 years.
- No Subject to a measure of legal protection (guardianship, curatorship or safeguard justice).
- Participation In other biomedical research or subjected to an exclusion period for another search.
- Not Unable to consent and are not subject to a protection measure.
- Not private freedom by administrative decision or court
- For TS patients (treated and untreated) and HV
- relative to MRI 3Tesla : pacemaker, cardiac cell or neural stimulator ferromagnetic surgical clips body intraocular or intracranial metallic foreign cochlear implant artificial heart valve or arterial metal surgical equipment metallic material that could concentrate the radio frequency pulses pregnant women, women in labor or lactating aneurism Standing up the eyelids vascular malformation of the brain
- Topic not wishing to be informed of a clinically significant abnormality discovered during the realization of MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".
Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics. Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source of these troubles. Its anatomical substrates is based on connections between frontal and striatal areas.
Initially, a battery of behavioral tests measuring different types of impulsivity (motor, cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40 patients treated and 40 untreated) and 40 healthy volunteers.
Read more
Then, investigators will study the fronto-striatal connections in the TS group of 80 patients (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging techniques (3T MRI). The techniques used will be functional connectivity study of "resting state" MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging data to highlight the functional anatomical substrates of impulsivity in patients with TS.
Finally, investigators will look specifically using functional MRI activation, the anatomical and functional substrates of the three types of impulsivity (motor, cognitive and decision-making).
Through this study, investigators hope to elucidate the anatomical and functional bases of cognitive impulsivity in patients with TS and thus lay the basis for more targeted treatments.
- Conditions
- Tourette Syndrome
- Being tested
- IRM and comportemental tasks
- Keywords
- cognitive impulsivity, IRM, Tourette Syndrome
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRM and comportemental tasksOther
| Study group | Role | What they receive |
|---|---|---|
| TREATED PATIENT WITH TOURETTE SYNDROME | Active comparator | comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients Receives: Other: IRM and comportemental tasks |
| UNTREATED PATIENT WITH TOURETTE SYNDROME | Active comparator | comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients Receives: Other: IRM and comportemental tasks |
| Healthy volunteers | Placebo comparator | comportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 80 subjects Receives: Other: IRM and comportemental tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
behavior performance (percentage of correct responses and reaction time)
Measured: up to one month
BOLD signal of functional MRI scan
Measured: up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2016 (estimated)
- Study start14 Oct 2016
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960698
- Sponsor's protocol ID
- C16-07
- Other IDs
- 2016-A00936-45
- Acronym
- COGIT
- Status last verified
- Aug 2021
- First submitted
- 27 Oct 2016
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Atkinson-Clement C, de Liege A, Klein Y, Beranger B, Valabregue R, Delorme C, Roze E, Fernandez-Egea E, Hartmann A, Robbins TW, Worbe Y. The sooner the better: clinical and neural correlates of impulsive choice in Tourette disorder. Transl Psychiatry. 2021 Nov 3;11(1):560. doi: 10.1038/s41398-021-01691-2.
PubMed 34732691Atkinson-Clement C, Sofia F, Fernandez-Egea E, de Liege A, Beranger B, Klein Y, Deniau E, Roze E, Hartmann A, Worbe Y. Structural and functional abnormalities within sensori-motor and limbic networks underpin intermittent explosive symptoms in Tourette disorder. J Psychiatr Res. 2020 Jun;125:1-6. doi: 10.1016/j.jpsychires.2020.02.033. Epub 2020 Mar 4.
PubMed 32169732Atkinson-Clement C, Porte CA, de Liege A, Wattiez N, Klein Y, Beranger B, Valabregue R, Sofia F, Hartmann A, Pouget P, Worbe Y. Neural correlates and role of medication in reactive motor impulsivity in Tourette disorder. Cortex. 2020 Apr;125:60-72. doi: 10.1016/j.cortex.2019.12.007. Epub 2019 Dec 30.
PubMed 31978743Atkinson-Clement C, Porte CA, de Liege A, Klein Y, Delorme C, Beranger B, Valabregue R, Gallea C, Robbins TW, Hartmann A, Worbe Y. Impulsive prepotent actions and tics in Tourette disorder underpinned by a common neural network. Mol Psychiatry. 2021 Jul;26(7):3548-3557. doi: 10.1038/s41380-020-00890-5. Epub 2020 Sep 29.
PubMed 32994553
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying the Neural Correlates of Cognitive Impulsivity in Patients With Tourette Syndrome. "COGIT".
- ClinicalTrials.gov ID
- NCT02960698
- Acronym / sponsor ID
- COGIT / C16-07
- Conditions
- Tourette Syndrome
- Keywords
- cognitive impulsivity, IRM, Tourette Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 10 Nov 2016 (estimated)
- 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.
Tourette syndrome (TS) is characterized by the presence of multiple vocal and motor tics. Behavioral disorders associated with TS are common, particularly impulsivity, anti-sociality and socially inappropriate behavior. Specifically, cognitive impulsivity could be the source of these troubles. Its anatomical substrates is based on connections between frontal and striatal areas.
Initially, a battery of behavioral tests measuring different types of impulsivity (motor, cognitive and decision) will be administered on three groups of subjects: TS: 80 patients (40 patients treated and 40 untreated) and 40 healthy volunteers.
Then, investigators will study the fronto-striatal connections in the TS group of 80 patients (40 patients treated and 40 untreated) compared to 40 healthy volunteers using neuroimaging techniques (3T MRI). The techniques used will be functional connectivity study of "resting state" MRI (RS-fMRI) combined with a reconstruction of white matter fibers by diffusion tensor imaging (DTI). Behavioral performance will be correlated with the correlation imaging data to highlight the functional anatomical substrates of impulsivity in patients with TS.
Finally, investigators will look specifically using functional MRI activation, the anatomical and functional substrates of the three types of impulsivity (motor, cognitive and decision-making).
Through this study, investigators hope to elucidate the anatomical and functional bases of cognitive impulsivity in patients with TS and thus lay the basis for more targeted treatments.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TREATED PATIENT WITH TOURETTE SYNDROME | Active comparator | Other: IRM and comportemental taskscomportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients |
| UNTREATED PATIENT WITH TOURETTE SYNDROME | Active comparator | Other: IRM and comportemental taskscomportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 40 patients |
| Healthy volunteers | Placebo comparator | Other: IRM and comportemental taskscomportemental tasks included impulsivity tests will performed at V1 Resting state IRM will be performed at V2 80 subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥ about 18 and 65 years old
- About receiving Social Security or universal health coverage or any equivalent plan
- About who signed the informed consent
- TS principal diagnosis, based on the DSM-5 criteria
- Stable pharmacological treatment at least 4 weeks prior to study entry;
Key exclusion criteria (22 listed)
- Age <18 years.
- Presence One of the following diagnoses Axis I DSM-5: schizophrenic disorders or current psychotic episode or in the past, bipolar disorder, current major depressive disorder autism spectrum.
- Abus Psychotropic substance dependency or a psychotropic substance, including alcohol (except nicotine).
- Support Regular / chronic drugs and other xenobiotics tropic psychotropic.
- Support Treatment with benzodiazepines in the 4 months prior to study entry. -Patient Subject to a measure of legal protection (guardianship, curatorship or safeguard justice). -No private freedom by administrative decision or justice.
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 |
|---|---|---|
| IRM and comportemental tasks | Other | Healthy volunteers, TREATED PATIENT WITH TOURETTE SYNDROME, UNTREATED PATIENT WITH TOURETTE SYNDROME |
Primary outcome
behavior performance (percentage of correct responses and reaction time)
Time frame: up to one month
BOLD signal of functional MRI scan
Time frame: up to one month
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 4 Sep 2025.
- Results publication: PubMed 34732691Atkinson-Clement C, de Liege A, Klein Y, Beranger B, Valabregue R, Delorme C, Roze E, Fernandez-Egea E, Hartmann A, Robbins TW, Worbe Y. The sooner the better: clinical and neural correlates of impulsive choice in Tourette disorder. Transl Psychiatry. 2021 Nov 3;11(1):560. doi: 10.1038/s41398-021-01691-2.
- Results publication: PubMed 32169732Atkinson-Clement C, Sofia F, Fernandez-Egea E, de Liege A, Beranger B, Klein Y, Deniau E, Roze E, Hartmann A, Worbe Y. Structural and functional abnormalities within sensori-motor and limbic networks underpin intermittent explosive symptoms in Tourette disorder. J Psychiatr Res. 2020 Jun;125:1-6. doi: 10.1016/j.jpsychires.2020.02.033. Epub 2020 Mar 4.
- Results publication: PubMed 31978743Atkinson-Clement C, Porte CA, de Liege A, Wattiez N, Klein Y, Beranger B, Valabregue R, Sofia F, Hartmann A, Pouget P, Worbe Y. Neural correlates and role of medication in reactive motor impulsivity in Tourette disorder. Cortex. 2020 Apr;125:60-72. doi: 10.1016/j.cortex.2019.12.007. Epub 2019 Dec 30.
- Results publication: PubMed 32994553Atkinson-Clement C, Porte CA, de Liege A, Klein Y, Delorme C, Beranger B, Valabregue R, Gallea C, Robbins TW, Hartmann A, Worbe Y. Impulsive prepotent actions and tics in Tourette disorder underpinned by a common neural network. Mol Psychiatry. 2021 Jul;26(7):3548-3557. doi: 10.1038/s41380-020-00890-5. Epub 2020 Sep 29.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRM and comportemental tasks in people with Tourette Syndrome, 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 15 inclusion and 22 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 4 Sep 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. Some participants in this study may receive a placebo. 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?
behavior performance (percentage of correct responses and reaction time) (time frame: up to one month). 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?
On the ClinicalTrials.gov record for NCT02960698, which also lists 4 linked publications.
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 4 Sep 2025.