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

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.

Study Overview

• Status: Recruiting
• Conditions: Tourette Syndrome
• Intervention / Treatment: Diagnostic test: Experimental MRI exam and PET scan exam with radiotracer

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine BREFEL-COURBON, MD; Phone Number: 33 05 61 77 94 91; Email: christine.brefel-courbon@univ-tlse3.fr

Study Locations

• France
  • Toulouse, France, 31059
    • Recruiting
    • Hôpital Pierre-Paul Riquet - CHU Toulouse
    • Contact: Christine BREFEL-COURBON, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient; patients with Gilles de la Tourette syndrome	Diagnostic test: Experimental MRI exam and PET scan exam with radiotracer; MRI exam and PET scan exam with radiotracer
Experimental: Control; healthy control	Diagnostic test: Experimental MRI exam and PET scan exam with radiotracer; MRI exam and PET scan exam with radiotracer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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	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	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Tourette Syndrome; PET-scan; physiopathology; the glutamatergic system
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Tourette Syndrome
• Other Study ID Numbers: RC31/15/7836; 2017-000816-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No