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Clinical Trials/NCT03681795
NCT03681795
Recruiting
Not Applicable

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

University Hospital, Toulouse1 site in 1 country24 target enrollmentNovember 26, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tourette Syndrome
Sponsor
University Hospital, Toulouse
Enrollment
24
Locations
1
Primary Endpoint
Correlation coefficients
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 26, 2018
End Date
December 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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).

Secondary Outcomes

  • Yale Brown Obsessive Compulsive Scale (Y-BOCS) - II(Day 1)
  • Barrat Impulsivity Scale 11(Day 1)
  • Yale Global Tic Severity Scale (YGTSS)(Day 1)
  • Hospital Anxiety Depression(Day 1)

Study Sites (1)

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