Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour) (GlutaTour)
Primary Purpose
Tourette Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Experimental MRI exam and PET scan exam with radiotracer
Sponsored by
About this trial
This is an interventional other trial for Tourette Syndrome focused on measuring Tourette Syndrome, the glutamatergic system, PET-scan, physiopathology
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
Sites / Locations
- Hôpital Pierre-Paul Riquet - CHU ToulouseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
patient
Control
Arm Description
patients with Gilles de la Tourette syndrome
healthy control
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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)
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
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.
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
Full Information
NCT ID
NCT03681795
First Posted
September 20, 2018
Last Updated
March 13, 2023
Sponsor
University Hospital, Toulouse
1. Study Identification
Unique Protocol Identification Number
NCT03681795
Brief Title
Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)
Acronym
GlutaTour
Official Title
Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 26, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome
Keywords
Tourette Syndrome, the glutamatergic system, PET-scan, physiopathology
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient
Arm Type
Experimental
Arm Description
patients with Gilles de la Tourette syndrome
Arm Title
Control
Arm Type
Experimental
Arm Description
healthy control
Intervention Type
Diagnostic Test
Intervention Name(s)
Experimental MRI exam and PET scan exam with radiotracer
Intervention Description
MRI exam and PET scan exam with radiotracer
Primary Outcome Measure Information:
Title
Correlation coefficients
Description
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).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Yale Global Tic Severity Scale (YGTSS)
Description
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)
Time Frame
Day 1
Title
Yale Brown Obsessive Compulsive Scale (Y-BOCS) - II
Description
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
Time Frame
Day 1
Title
Hospital Anxiety Depression
Description
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.
Time Frame
Day 1
Title
Barrat Impulsivity Scale 11
Description
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
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine BREFEL-COURBON, MD
Phone
05 61 77 94 91
Ext
33
Email
christine.brefel-courbon@univ-tlse3.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine BREFEL-COURBON, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pierre-Paul Riquet - CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine BREFEL-COURBON, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour)
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