Tourette SyndromeGlutaTourNCT03681795
Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)
A study testing Experimental MRI exam and PET scan exam with radiotracer in people with Tourette Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Experimental MRI exam and PET scan exam with radiotracer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 26 Nov 2018to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gilles de la Tourette syndrome according to the American Psychiatric association criteria (5 th ed, American Psychiatric association (APA), 2013)
- Aged 18 and over
- Patients treated with 2nd-generation neuroleptics for at least 3months
- Signed consent form
Who cannot join
- contraindications for MRI exam
- claustrophobia
- person under exclusive period for another study
- pregnant women
- patients under non-authorized treatment (1rst generation neuroleptics) or non-treated by neuroleptics
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Pierre-Paul Riquet - CHU Toulouse
Toulouse, 31059
Christine BREFEL-COURBON, MD
About this study
Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear.
Read the detailed description
Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear. It would involve an alteration of striatal-cortico-thalamic cortical circuits resulting in dopaminergic dysfunction. But glutamatergic hypothesis is also discussed from pharmacological, biochemical and genetic arguments. Exploration of glutamatergic system can be done in humans in vivo using a new radiotracer: the [18F] FNM (Fluoroethylnormemantine), a derivative of memantine. In the present study, aim of the study 1) to show the glutamatergic system "in vivo" in patients with Tourette's syndrome and 2) to perform correlations between various motor and behavioral symptoms and the pattern of brain fixation for this radiotracer. To do that, a pilot study will be conducted in 12 patients with Tourette's who will be evaluated in terms of motor (tics) and behavioral (OCD, anxiety, depression, impulsivity) symptoms. Each patient will have a PET-scan exam and a brain MRI exam. Data analysis will be carried out from two different approaches: first by region of interest, and secondly, without topographic a priori with the Statistical Parametric Mapping (SPM) software.
- Conditions
- Tourette Syndrome
- Being tested
- Experimental MRI exam and PET scan exam with radiotracer
- Keywords
- Tourette Syndrome, the glutamatergic system, PET-scan, physiopathology
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental MRI exam and PET scan exam with radiotracerDiagnostic test
MRI exam and PET scan exam with radiotracer
| Study group | Role | What they receive |
|---|---|---|
| patient | Experimental | patients with Gilles de la Tourette syndrome Receives: Diagnostic Test: Experimental MRI exam and PET scan exam with radiotracer |
| Control | Experimental | healthy control Receives: Diagnostic Test: Experimental MRI exam and PET scan exam with radiotracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation coefficients
Correlation coefficients is determined between the fixation of the PET tracer and the Total Tic score (TTS - from 0 to 50) which reflects the severity of tics in patients (under the Yale Global Tic Severity Scale - YGTSS)(Leckman and al, 1989).
Measured: Day 1
Secondary outcomes (4)
Yale Global Tic Severity Scale (YGTSS)
This scale represents the severity of tics in patients, it is a scale composed of three subscales:
- Motor tic severity from 0 to 25,
- Vocal Tic severity from 0 to 25,
- Overall Impairment from 0 to 50, which reflects the functional impairment score (under Yale Global Tic Severity Scale - YGTSS). This score assesses the repercussions of the syndrome on self-esteem, and the social, professional and family.
For each of the sub-scales, tics are rated according to their number, frequency, intensity, complexity, interference with activities of everyday life.
The sum of Motor Tic severity and Vocal Tic severity form the Total Tic score (0 to 50)
Measured: Day 1
Yale Brown Obsessive Compulsive Scale (Y-BOCS) - II
Yale Brown Obsessive Compulsive Scale consists of 19 questions aimed at evaluating the severity, the impact on daily, social, family and professional life activities of OCD, the anxieties generated by OCD Higher values represent a worse outcome
Measured: Day 1
Hospital Anxiety Depression
Hospital Anxiety Depression (from 0 to 42) which is a self-questionnaire of 14 items:
- 7 items refer to anxiety,
- 7 items refer to depression. Each item is scored from 0 to 3 This scale explores anxiety and depressive symptoms. Total the anxiety and depression side: maximum 21 points for each.
Between 8 and 10: doubtful anxiety or depressive state. Beyond 10: certain anxiety or depression.
Measured: Day 1
Barrat Impulsivity Scale 11
Barrat Impulsivity Scale 11 is self-assessment scale with 34 items. It provides an assessment of impulsivity according to motor impulsivity, cognitive impulsivity and planning difficulty. Each item is scored on 4, the total score therefore varies from 0 to 120
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start26 Nov 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Model description
- compare PET-evaluated glutamaergic system activity (\[18F\]-FNM) between patients with Gilles de la Tourette and healthy volunteers paired in sex, age and manual laterality
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine BREFEL-COURBON, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681795
- Sponsor's protocol ID
- RC31/15/7836
- Other IDs
- 2017-000816-40, 2017
- Acronym
- GlutaTour
- Status last verified
- Mar 2023
- First submitted
- 20 Sep 2018
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)
- ClinicalTrials.gov ID
- NCT03681795
- Acronym / sponsor ID
- GlutaTour / RC31/15/7836
- Conditions
- Tourette Syndrome
- Keywords
- Tourette Syndrome, the glutamatergic system, PET-scan, physiopathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Sep 2018 (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.
Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear.
Detailed description
Gilles de la Tourette syndrome is a neuropsychiatric disorder characterized by motor and vocal tics often associated with psychiatric comorbidities (obsessive compulsive disorder, anxiety and depressive syndrome, impulsivity). The pathophysiology of Gilles de la Tourette syndrome remains unclear. It would involve an alteration of striatal-cortico-thalamic cortical circuits resulting in dopaminergic dysfunction. But glutamatergic hypothesis is also discussed from pharmacological, biochemical and genetic arguments. Exploration of glutamatergic system can be done in humans in vivo using a new radiotracer: the [18F] FNM (Fluoroethylnormemantine), a derivative of memantine. In the present study, aim of the study 1) to show the glutamatergic system "in vivo" in patients with Tourette's syndrome and 2) to perform correlations between various motor and behavioral symptoms and the pattern of brain fixation for this radiotracer. To do that, a pilot study will be conducted in 12 patients with Tourette's who will be evaluated in terms of motor (tics) and behavioral (OCD, anxiety, depression, impulsivity) symptoms. Each patient will have a PET-scan exam and a brain MRI exam. Data analysis will be carried out from two different approaches: first by region of interest, and secondly, without topographic a priori with the Statistical Parametric Mapping (SPM) software.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- compare PET-evaluated glutamaergic system activity ([18F]-FNM) between patients with Gilles de la Tourette and healthy volunteers paired in sex, age and manual laterality
| Arm | Type | Receives |
|---|---|---|
| patient | Experimental | Diagnostic Test: Experimental MRI exam and PET scan exam with radiotracerpatients with Gilles de la Tourette syndrome |
| Control | Experimental | Diagnostic Test: Experimental MRI exam and PET scan exam with radiotracerhealthy control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Gilles de la Tourette syndrome according to the American Psychiatric association criteria (5 th ed, American Psychiatric association (APA), 2013)
- Aged 18 and over
- Patients treated with 2nd-generation neuroleptics for at least 3months
- Signed consent form
Key exclusion criteria (5 listed)
- contraindications for MRI exam
- claustrophobia
- person under exclusive period for another study
- pregnant women
- patients under non-authorized treatment (1rst generation neuroleptics) or non-treated by neuroleptics
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 |
|---|---|---|
| Experimental MRI exam and PET scan exam with radiotracerMRI exam and PET scan exam with radiotracer | Diagnostic test | Control, patient |
Primary outcome
Correlation coefficients
Time frame: Day 1
Correlation coefficients is determined between the fixation of the PET tracer and the Total Tic score (TTS - from 0 to 50) which reflects the severity of tics in patients (under the Yale Global Tic Severity Scale - YGTSS)(Leckman and al, 1989).
4 secondary outcomes
Yale Global Tic Severity Scale (YGTSS)
Time frame: Day 1
Yale Brown Obsessive Compulsive Scale (Y-BOCS) - II
Time frame: Day 1
Hospital Anxiety Depression
Time frame: Day 1
Barrat Impulsivity Scale 11
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- 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.
Christine BREFEL-COURBON, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental MRI exam and PET scan exam with radiotracer in people with Tourette Syndrome, run by University Hospital, Toulouse 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 5 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: status not confirmed, as of the sponsor's last update on 16 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine BREFEL-COURBON, MD (05 61 77 94 91 ext. 33, christine.brefel-courbon@univ-tlse3.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficients (time frame: Day 1). 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 16 Mar 2023.