Gilles de la Tourette Syndrome (TS) and Seasonality

NCT04076852 | Terminated

• 2 other identifiers: Stagionalità TS (PI: M Porta)L3036
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from baseline Y-BOCS score at 6 months.

  4, 8, 12 months.

Interventions

Administration of questionnaires OTHER

According to clinical practice, the following questionnaires are administered: * Y-GTSS * Y-BOCS or cY-BOCS

Eligibility Criteria

• Age: 6 Years - 50 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Galeazzi Hospital

Milan, Lombardy, 20161, Italy

Location

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

• Mauro Porta

  IRCCS Orthopedic Institute Galeazzi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: September 3, 2019
• Study Start: April 6, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: May 9, 2023

Record last verified: 2019-08

Locations

IT (1)