- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290920
Sensorimotor Integration in Patients With Tourette Syndrome (ISM)
Sensorimotor Integration in Patients With Tourette Syndrome: an Observational Study.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Italy
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Milan, Italy, Italy, 20100
- IRCCS Ospedale Galeazzi-Sant'Ambrogio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Tourette Syndrome Patients
Patients affected by Tourette Syndrome
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Healthy controls
Individuals without neurological or psychiatric disorders
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Magnitude of sensory attenuation (difference between self-generated and externally generated force reproduction)
Time Frame: Day 1
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Sensory attenuation
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Day 1
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Collaborators and Investigators
Publications and helpful links
General 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.
- Zapparoli 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.
- Brown 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Genetic Diseases, Inborn
- Neurodegenerative Diseases
- Neurodevelopmental Disorders
- Movement Disorders
- Heredodegenerative Disorders, Nervous System
- Basal Ganglia Diseases
- Tic Disorders
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Tourette Syndrome
Other Study ID Numbers
- ISM_L3053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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