Tourette DisorderISMNCT07290920
Sensorimotor Integration in Patients With Tourette Syndrome
An observational study of Tourette Disorder and Sensory Gating, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The present study investigates the mechanisms underlying the sense of agency in patients with Tourette Syndrome (TS). Previous research has shown that individuals with TS display impairments in both explicit and implicit aspects of agency, possibly due to altered integration between sensory feedback and motor… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tourette Disorder, Sensory Gating
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 20 Mar 2025to 3 Dec 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include adult participants aged 18 to 65 years, comprising two groups: individuals diagnosed with Tourette Syndrome (TS) and healthy control participants. The Tourette group will consist of patients meeting DSM-5 diagnostic criteria for Tourette Syndrome, recruited through specialized neurological and neuropsychiatric clinics. Healthy controls will be recruited from the general population and will be matched to the TS group for age, sex, and education level.
Who may be able to join
- For Tourette Syndrome group:
- Clinical diagnosis of Tourette Syndrome (TS) according to DSM-5 criteria
- Age between 18 and 65 years
- Ability to understand and comply with study procedures
- Written informed consent provided
- For Healthy Control group:
Show all 11Show fewer
- No current or past history of neurological or psychiatric disorders
- Age between 18 and 65 years
- Matched to the TS group for age, sex, and education level
- Ability to understand and comply with study procedures
- Written informed consent provided
Who cannot join
- History of significant neurological disorders (e.g., brain injury or dementia) or major psychiatric disorders (with the exception of conditions commonly associated with Tourette Syndrome, such as Obsessive-Compulsive Disorder, ADHD, depression, and anxiety);
- Failure or refusal to provide written informed consent;
- Confirmed pregnancy (self-reported) and/or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensorimotor Integration in Patients With Tourette Syndrome: an Observational Study.
The present study investigates the mechanisms underlying the sense of agency in patients with Tourette Syndrome (TS). Previous research has shown that individuals with TS display impairments in both explicit and implicit aspects of agency, possibly due to altered integration between sensory feedback and motor predictions. To explore this hypothesis, the study will examine the phenomenon of sensory attenuation, a marker of sensorimotor integration that has not yet been investigated in this population. Furthermore, the study will assess how alterations in sensorimotor integration are related to the severity of TS symptoms.
Read the detailed description
The present study aims to investigate the mechanisms underlying the sense of agency in patients with Tourette Syndrome (TS). Previous evidence indicates that individuals with TS exhibit abnormalities in both explicit and implicit (absent intentional binding) experiences of agency. According to a recent theoretical framework, such alterations may stem from impaired sensorimotor integration - specifically, a dysfunction in the ability to combine sensory feedback with motor predictions about the consequences of one's own actions. This deficit may not only affect motor control but also the awareness of self-generated movements, thereby compromising the distinction between self-produced and externally produced actions.
To test this hypothesis, the study will employ the Force Matching Task (FMT), a well-established paradigm used to assess sensory attenuation - the reduced perception of intensity for self-generated sensations compared to externally generated ones. In this task, participants are asked to reproduce a force applied to their finger either by pressing directly with their own finger (self-generated condition) or by controlling a mechanical device (externally generated condition). In healthy individuals, self-generated forces are typically perceived as weaker due to predictive motor mechanisms. A reduced or absent sensory attenuation effect would indicate altered sensorimotor integration.
The primary aim of the study is therefore to evaluate whether patients with Tourette Syndrome show atypical sensory attenuation compared to healthy controls, as an index of altered sensorimotor integration underlying the sense of agency. The secondary aim is to examine the relationship between the degree of sensory attenuation and clinical symptom severity, to determine whether deficits in sensorimotor integration are associated with the intensity of tic expression or other clinical features of the disorder.
- Conditions
- Tourette Disorder, Sensory Gating
- Keywords
- Tourette Syndrome, Sense of agency, Sensorimotor integration, Sensory attenuation, Motor control, Predictive processing
- Medical subject headings
- Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tourette Syndrome Patients | Patients affected by Tourette Syndrome | |
| Healthy controls | Individuals without neurological or psychiatric disorders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of sensory attenuation (difference between self-generated and externally generated force reproduction)
Sensory attenuation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start20 Mar 2025
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tourette DisorderStudies 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
- Cross-sectional
- Enrolment
- 60 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290920
- Sponsor's protocol ID
- ISM_L3053
- Acronym
- ISM
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delorme C, Salvador A, Voon V, Roze E, Vidailhet M, Hartmann A, Worbe Y. Illusion of agency in patients with Gilles de la Tourette Syndrome. Cortex. 2016 Apr;77:132-140. doi: 10.1016/j.cortex.2016.02.003. Epub 2016 Feb 17.
PubMed 26963083Zapparoli L, Seghezzi S, Zirone E, Guidali G, Tettamanti M, Banfi G, Bolognini N, Paulesu E. How the effects of actions become our own. Sci Adv. 2020 Jul 1;6(27):eaay8301. doi: 10.1126/sciadv.aay8301. Print 2020 Jul.
PubMed 32937445Brown H, Adams RA, Parees I, Edwards M, Friston K. Active inference, sensory attenuation and illusions. Cogn Process. 2013 Nov;14(4):411-27. doi: 10.1007/s10339-013-0571-3. Epub 2013 Jun 7.
PubMed 23744445
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Integration in Patients With Tourette Syndrome: an Observational Study.
- ClinicalTrials.gov ID
- NCT07290920
- Acronym / sponsor ID
- ISM / ISM_L3053
- Conditions
- Tourette Disorder, Sensory Gating
- Keywords
- Tourette Syndrome, Sense of agency, Sensorimotor integration, Sensory attenuation, Motor control, Predictive processing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 18 Dec 2025 (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 present study investigates the mechanisms underlying the sense of agency in patients with Tourette Syndrome (TS). Previous research has shown that individuals with TS display impairments in both explicit and implicit aspects of agency, possibly due to altered integration between sensory feedback and motor predictions. To explore this hypothesis, the study will examine the phenomenon of sensory attenuation, a marker of sensorimotor integration that has not yet been investigated in this population. Furthermore, the study will assess how alterations in sensorimotor integration are related to the severity of TS symptoms.
Detailed description
The present study aims to investigate the mechanisms underlying the sense of agency in patients with Tourette Syndrome (TS). Previous evidence indicates that individuals with TS exhibit abnormalities in both explicit and implicit (absent intentional binding) experiences of agency. According to a recent theoretical framework, such alterations may stem from impaired sensorimotor integration - specifically, a dysfunction in the ability to combine sensory feedback with motor predictions about the consequences of one's own actions. This deficit may not only affect motor control but also the awareness of self-generated movements, thereby compromising the distinction between self-produced and externally produced actions.
To test this hypothesis, the study will employ the Force Matching Task (FMT), a well-established paradigm used to assess sensory attenuation - the reduced perception of intensity for self-generated sensations compared to externally generated ones. In this task, participants are asked to reproduce a force applied to their finger either by pressing directly with their own finger (self-generated condition) or by controlling a mechanical device (externally generated condition). In healthy individuals, self-generated forces are typically perceived as weaker due to predictive motor mechanisms. A reduced or absent sensory attenuation effect would indicate altered sensorimotor integration.
The primary aim of the study is therefore to evaluate whether patients with Tourette Syndrome show atypical sensory attenuation compared to healthy controls, as an index of altered sensorimotor integration underlying the sense of agency. The secondary aim is to examine the relationship between the degree of sensory attenuation and clinical symptom severity, to determine whether deficits in sensorimotor integration are associated with the intensity of tic expression or other clinical features of the disorder.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tourette Syndrome Patients | – | –Patients affected by Tourette Syndrome |
| Healthy controls | – | –Individuals without neurological or psychiatric disorders |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult participants aged 18 to 65 years, comprising two groups: individuals diagnosed with Tourette Syndrome (TS) and healthy control participants. The Tourette group will consist of patients meeting DSM-5 diagnostic criteria for Tourette Syndrome, recruited through specialized neurological and neuropsychiatric clinics. Healthy controls will be recruited from the general population and will be matched to the TS group for age, sex, and education level.
Key inclusion criteria (11 listed)
- Clinical diagnosis of Tourette Syndrome (TS) according to DSM-5 criteria
- Age between 18 and 65 years
- Ability to understand and comply with study procedures
- Written informed consent provided
- No current or past history of neurological or psychiatric disorders
Key exclusion criteria (3 listed)
- History of significant neurological disorders (e.g., brain injury or dementia) or major psychiatric disorders (with the exception of conditions commonly associated with Tourette Syndrome, such as Obsessive-Compulsive Disorder, ADHD, depression, and anxiety);
- Failure or refusal to provide written informed consent;
- Confirmed pregnancy (self-reported) and/or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Magnitude of sensory attenuation (difference between self-generated and externally generated force reproduction)
Time frame: Day 1
Sensory attenuation
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 18 Dec 2025.
- Background: PubMed 26963083Delorme C, Salvador A, Voon V, Roze E, Vidailhet M, Hartmann A, Worbe Y. Illusion of agency in patients with Gilles de la Tourette Syndrome. Cortex. 2016 Apr;77:132-140. doi: 10.1016/j.cortex.2016.02.003. Epub 2016 Feb 17.
- Background: PubMed 32937445Zapparoli L, Seghezzi S, Zirone E, Guidali G, Tettamanti M, Banfi G, Bolognini N, Paulesu E. How the effects of actions become our own. Sci Adv. 2020 Jul 1;6(27):eaay8301. doi: 10.1126/sciadv.aay8301. Print 2020 Jul.
- Background: PubMed 23744445Brown H, Adams RA, Parees I, Edwards M, Friston K. Active inference, sensory attenuation and illusions. Cogn Process. 2013 Nov;14(4):411-27. doi: 10.1007/s10339-013-0571-3. Epub 2013 Jun 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disorder and Sensory Gating, 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 11 inclusion and 3 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 18 Dec 2025. 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?
Magnitude of sensory attenuation (difference between self-generated and externally generated force reproduction) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07290920, which also lists 3 linked publications.
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 18 Dec 2025.