Tourette SyndromeNCT04197804
Impulse Control in Gilles de la Tourette Syndrome
An observational study of Tourette Syndrome, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- Routine tests perform
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 2 May 2018to 30 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
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%;
Who may be able to join
- 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)
Show all 13Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tourette Syndrome
- Being tested
- Routine tests perform
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine tests performOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine tests perform |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start2 May 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauro Porta, Principal investigator, IRCCS Istituto Ortopedico Galeazzi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197804
- Sponsor's protocol ID
- Nessie (PI: M Porta)
- Other IDs
- L3035
- Status last verified
- May 2023
- First submitted
- 29 Dec 2018
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study.
- ClinicalTrials.gov ID
- NCT04197804
- Acronym / sponsor ID
- Nessie (PI: M Porta)
- Conditions
- Tourette Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourette group | – | Other: Routine tests perform20 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. |
| Control group | – | Other: Routine tests perform20 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. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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%;
Key inclusion criteria (13 listed)
- TOURETTE GROUP
- Consecutive patients belonging to the Tourette Center
- Caucasian
- Italian mother-tongue
- Age between 6 and 10 years completed
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine tests performThe 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. | Other | Control group, Tourette group |
Primary outcome
Tourette syndrome and the imitation of gestures
Time frame: Through study completion, an average of 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Porta principal investigator
IRCCS Istituto Ortopedico Galeazzi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tourette Syndrome, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tourette syndrome and the imitation of gestures (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.