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CompletedNCT04197804Updated May 9, 2023

Impulse Control in Gilles de la Tourette Syndrome

An observational study in Tourette Syndrome, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Completed at 1 site in Italy. Open to participants aged 6 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
40
Ages
6 Years to 10 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Tourette Syndrome
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In context

Tourette Syndrome

220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 43 observational studies indexed under Tourette Syndrome.

Browse Tourette Syndrome studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 157 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
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%;

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherRoutine 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.

06

What researchers measure

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

    Time frame: Through study completion, an average of 1 year

07

Study locations

1 site
  • IRCCS Istituto Ortopedico Galeazzi
    Milan, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04197804
Lead sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible party
Sponsor
First posted
Dec 13, 2019
Start date
May 2, 2018
Primary completion
Apr 30, 2019
Completion
Apr 30, 2019
Last update
May 9, 2023

Study contacts

Mauro Porta
principal investigator · IRCCS Istituto Ortopedico Galeazzi

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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