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

NCT03681795 | Unknown

• 2 other identifiers: RC31/15/78362017-000816-40
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome

Keywords

Tourette Syndrome; the glutamatergic system; PET-scan; physiopathology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Yale Global Tic Severity Scale (YGTSS)

  Day 1

• Yale Brown Obsessive Compulsive Scale (Y-BOCS) - II

  Day 1

• Hospital Anxiety Depression

  Day 1

• Barrat Impulsivity Scale 11

  Day 1

Study Arms (2)

patient

EXPERIMENTAL

patients with Gilles de la Tourette syndrome

Diagnostic Test: Experimental MRI exam and PET scan exam with radiotracer

Control

EXPERIMENTAL

healthy control

Diagnostic Test: Experimental MRI exam and PET scan exam with radiotracer

Interventions

Experimental MRI exam and PET scan exam with radiotracer DIAGNOSTIC_TEST

MRI exam and PET scan exam with radiotracer

Control; patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital Pierre-Paul Riquet - CHU Toulouse

Toulouse, 31059, France

RECRUITING

MeSH Terms

Conditions

Tourette Syndrome

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Christine BREFEL-COURBON, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine BREFEL-COURBON, MD

CONTACT

05 61 77 94 91; christine.brefel-courbon@univ-tlse3.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 24, 2018
• Study Start: November 26, 2018
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)