Impulse Control in Gilles de la Tourette Syndrome

NCT04197804 | Completed

• 2 other identifiers: Nessie (PI: M Porta)L3035
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study intends to evaluate the role of Mirror Neurons in the determination of gestures, words, and repetitive vocalizations in subjects affected by Tourette's syndrome and to verify if these subjects are faster to assemble sounds, in phonology and morphology, than the non-pathological population.

Conditions

Tourette Syndrome

Outcome Measures

Primary Outcomes (1)

• Tourette syndrome and the imitation of gestures

  The aim is to investigate the correlation between Mirror Neurons and Tourette Syndrome defining the greater propensity of the Tourettian subjects to imitate gestures, through the administration of the first Task

  Through study completion, an average of 1 year

Study Arms (2)

Tourette group

20 subjects with Tourette Syndrome undergoing an evaluation to identify the IQ. Subsequently, 4 tasks are presented. The 1st (with a duration of about 2 and a half minutes) and the 2nd (with a duration of about 2 minutes) concerning the motor field, the 3rd (with duration of about 1 minute) and the 4th (with duration of about 3 minutes) concerning the linguistic field.

Other: Routine tests perform

Control group

20 subjects without Tourette Syndrome subjected to an evaluation to identify the IQ. Subsequently 4 tasks are presented. The 1st (with a duration of about 2 and a half minutes) and the 2nd (with a duration of about 2 minutes) concerning the motor field, the 3rd (with duration of about 1 minute) and the 4th (with duration of about 3 minutes) concerning the linguistic field.

Other: Routine tests perform

Interventions

Routine tests perform OTHER

The subjects of the Tourette group and control group are subjected to routine tests performed at Tourette Center and Extrapyramidal Diseases. Both groups are initially subjected to an evaluation that aims to identify the IQ and therefore 4 tasks are presented. The 1st (with a duration of about 2 and a half minutes) and the 2nd (with a duration of about 2 minutes) related to the motor field, the 3rd (with duration of about 1 minute) and the 4th (with duration about 3 minutes) the language field. These evaluations are in practice at the Center for Tourette patients; the tasks will be administered to both groups.

Control group; Tourette group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

The calculated sample size is 20 subjects per arm considering: 1. error of I type with two queues = 0.05; 2. Type II error β = 0.20, which corresponds to a test power (1-β = 0.80) of 80%; 3. a clinically significant difference of 4%;

You may qualify if:

• TOURETTE GROUP
• Consecutive patients belonging to the Tourette Center
• Caucasian
• Italian mother-tongue
• Age between 6 and 10 years completed
• Male and female 4: 1 (16 males and 4 females)
• Diagnosis of Tourette's syndrome for at least 1 year
• Presence of a value of YGTSS\> 50%
• NOT GROUP TOURETTE
• Caucasian
• Italian mother-tongue
• Age between 6 and 10 years completed
• Male and female 4: 1 (16 males and 4 females)

You may not qualify if:

• TOURETTE GROUP
• Diagnosis of DSA
• Presence of significant psychiatric disorders, with the exception of those belonging to the Tourette Syndrome itself (eg ADHD, OCD).
• NOT GROUP TOURETTE
• Diagnosis of DSA
• Presence of significant psychiatric disorders

Sponsors & Collaborators

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

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 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 Istituto Ortopedico Galeazzi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: December 13, 2019
• Study Start: May 2, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

IT (1)