- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04076852
Gilles de la Tourette Syndrome (TS) and Seasonality
May 8, 2023 updated by: Istituto Ortopedico Galeazzi
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
39
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Lombardy
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Milan, Lombardy, Italy, 20161
- IRCCS Galeazzi Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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.
Time Frame: 4, 8, 12 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.
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4, 8, 12 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Y-BOCS score at 6 months.
Time Frame: 4, 8, 12 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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mauro Porta, IRCCS Orthopedic Institute Galeazzi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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