Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)

NCT ID: NCT03681795

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-26

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Tourette Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patient

patients with Gilles de la Tourette syndrome

Group Type EXPERIMENTAL

Experimental MRI exam and PET scan exam with radiotracer

Intervention Type DIAGNOSTIC_TEST

MRI exam and PET scan exam with radiotracer

Control

healthy control

Group Type EXPERIMENTAL

Experimental MRI exam and PET scan exam with radiotracer

Intervention Type DIAGNOSTIC_TEST

MRI exam and PET scan exam with radiotracer

Interventions

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Experimental MRI exam and PET scan exam with radiotracer

MRI exam and PET scan exam with radiotracer

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christine BREFEL-COURBON, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Hôpital Pierre-Paul Riquet - CHU Toulouse

Toulouse, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Christine BREFEL-COURBON, MD

Role: CONTACT

05 61 77 94 91 ext. 33

Facility Contacts

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Christine BREFEL-COURBON, MD

Role: primary

Other Identifiers

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2017-000816-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RC31/15/7836

Identifier Type: -

Identifier Source: org_study_id

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