Clinical trial NCT03681795: Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)
Official title: Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourette Syndrome
Keywords: Tourette Syndrome
the glutamatergic system
PET-scan
physiopathology
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Correlation coefficients
timeFrame: Day 1
Secondary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Day 1
measure: Yale Brown Obsessive Compulsive Scale (Y-BOCS) - II
timeFrame: Day 1
measure: Hospital Anxiety Depression
timeFrame: Day 1
measure: Barrat Impulsivity Scale 11
timeFrame: Day 1
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Pierre-Paul Riquet - CHU Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Christine BREFEL-COURBON, MD
role: PRINCIPAL_INVESTIGATOR
References: