Gilles de la Tourette Syndrome (TS) and Seasonality

Tourette Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04076852
• Other study ID #: Stagionalità TS (PI: M Porta)
• Secondary ID: L3036
• Status: Terminated
• Start date: April 6, 2018
• Est. completion date: May 31, 2019

Study information

• Verified date: August 2019
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Gender: All
• Age group: 6 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Other:
• Administration of questionnaires
According to clinical practice, the following questionnaires are administered: Y-GTSS Y-BOCS or cY-BOCS

Locations

Country	Name	City	State
Italy	IRCCS Galeazzi Hospital	Milan	Lombardy

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.