Gilles de la Tourette Syndrome (TS) and Seasonality

Gilles de la Tourette Syndrome (TS) and Seasonality: a Pilot Study

This retrospective and prospective observational study intends to evaluate the correlation between seasons and the variation of the syndromic structure of the Tourette.

Study Overview

• Status: Terminated
• Conditions: Tourette Syndrome
• Intervention / Treatment: Other: Administration of questionnaires

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Milan, Lombardy, Italy, 20161
      • IRCCS Galeazzi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Being a pilot study it was not possible to develop a sample study, but the sample number is designed based on the tourette center turnout

Description

Inclusion Criteria:

• Patients attending the Tourette Center since January 2012.
• Males and females.
• Age between 6 and 50 (completed).
• Diagnosis of Tourette syndrome ascertained
• Presence of a value equal to or greater than 15/40 of the Y-BOCS.

Exclusion Criteria:

• Presence of allergic pathology.
• Presence of significant psychiatric symptoms, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Y-GTSS score at 6 months.	The primary objective is to investigate the correlation between seasons and different phenotypic variation through the administration of a specific questionnaire (Y-GTSS) and questions about the subjective perception of the ticcogenic variation.	4, 8, 12 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Y-BOCS score at 6 months.	Secondary objective is to investigate the correlation between seasons and variation of severity of obsessive-compulsive disorder (OCD) through the administration of Y-BOCS, a questionnaire indicated to evaluate the severity of obsessive-compulsive disorder.	4, 8, 12 months.

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Investigators: Principal Investigator: Mauro Porta, IRCCS Orthopedic Institute Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: December 29, 2018
• First Submitted That Met QC Criteria: August 30, 2019
• First Posted (Actual): September 3, 2019

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: Stagionalità TS (PI: M Porta); L3036 (Other Grant/Funding Number: Italian Ministry of Health)

Drug and device information, study documents

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