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

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Brief Title

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)

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 glutamaergic 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
      (Fluoroéthylnormémantine), 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 SPM software.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Correlation coefficients

Secondary Outcome

 Yale Global Tic Severity Scale

Condition

Gilles de la Tourette Syndrome

Intervention

Experimental MRI exam and PET scan exam

Study Arms / Comparison Groups

 Experimental
Description:  Experimental MRI exam and PET scan exam without comparator. Patients evaluated on motor and behavioral symptoms.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Combination Product

Estimated Enrollment

12

Start Date

December 2018

Completion Date

December 2020

Primary Completion Date

June 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Gilles de la Tourette syndrome according to the American Psychiatric association
             criteria (5 th ed, 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Christine BREFEL-COURBON, MD, 05 61 77 94 91, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations

NCT ID

NCT03681795

Organization ID

15 7836 03

Secondary IDs

2017-000816-40

Responsible Party

Sponsor

Study Sponsor

University Hospital, Toulouse

Study Sponsor

Christine BREFEL-COURBON, MD, Principal Investigator, University Hospital, Toulouse

Verification Date

September 2018