Impulse Control in Gilles de la Tourette Syndrome (NESSIE)

Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study.

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.

Study Overview

• Status: Completed
• Conditions: Tourette Syndrome
• Intervention / Treatment: Other: Routine tests perform

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • IRCCS Istituto Ortopedico Galeazzi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

• 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%;

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: December 29, 2018
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

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

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: Nessie (PI: M Porta); L3035 (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