Motor ActivitySOANCT03361332
The Sense of Agency
An observational study of Motor Activity and Motor Tic Disorders, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
The ability to recognize of being the actors of the behaviour and its consequences, the so-called "Sense of Agency" (SoA), is a crucial component of self-awareness. One key aspect is the distinction from a mere inference about the causality between an act and its consequences and the sense of being the agent of it. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Motor Activity, Motor Tic Disorders
- What is being tested?
- Behavioral and fMRI
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 8 Apr 2017to 23 Jan 2020
- 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
- Adult, Older adult
Study population: Healthy controls and patients with Gilles de la Tourette Syndrome
Who may be able to join
- Age included between 18 and 65 years
- Right handed
- No contraindication to the fMRI exam
Who cannot join
- Contraindication to the fMRI exam
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Galeazzi Orthopedic Hospital
Milan, 20161
Sara Zacchetti, +390266214057, sara.zacchetti@grupposandonato.it
Eraldo Paulesu
About this study
Official title: Behavioural and Neurofunctional Correlates of the Sense of Agency
The ability to recognize of being the actors of the behaviour and its consequences, the so-called "Sense of Agency" (SoA), is a crucial component of self-awareness. One key aspect is the distinction from a mere inference about the causality between an act and its consequences and the sense of being the agent of it. Despite a large number of behavioural studies, there is unsatisfactory evidence on the functional anatomical underpinnings of the SoA and the distinction between causality and the SoA proper. Here, the investigators use an implicit measurement of the SoA and its modulations during fMRI: the intentional binding phenomenon (IB). The ivestigators also study how the SoA and the ensuing neurophysiological correlates are modulated by the presence of a movement disorders, such as Gilles de la Tourette Syndrome.
- Conditions
- Motor Activity, Motor Tic Disorders
- Being tested
- Behavioral and fMRI
- Medical subject headings
- Motor Activity, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral and fMRIOther
Subjects and patients will perform temporal-judgment-tasks (considered an indirect measure of the sense of agency) in an event-related fMRI setting. In the first task, they will hear a sound either caused by a voluntary key press or by the passive displacement of the same finger by the experimenter. Following each trial, subjects will estimate the delay between the finger movement and the subsequent sound, which will be presented at variable latencies after the key press. There will be also control-trials characterized by the active or passive movement with a subsequent sound presented with a delay that excludes causality inferences.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Not described Receives: Other: Behavioral and fMRI | |
| Patients with Gilles de la Tourette Syndrome | Not described Receives: Other: Behavioral and fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal changes
The investigators will measure the changes of the BOLD signal associated with the modification of the sense of agency both in healthy subjects and neurological patients.
Measured: April 2017 - October 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start8 Apr 2017
- Primary completion29 Jul 2017
- Study completion23 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
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
- NCT03361332
- Sponsor's protocol ID
- SOA
- Acronym
- SOA
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioural and Neurofunctional Correlates of the Sense of Agency
- ClinicalTrials.gov ID
- NCT03361332
- Acronym / sponsor ID
- SOA / SOA
- Conditions
- Motor Activity, Motor Tic Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 8 Apr 2017 (actual)
- Primary completion
- 29 Jul 2017 (actual)
- Study completion
- 23 Jan 2020 (estimated)
- First posted
- 4 Dec 2017 (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 ability to recognize of being the actors of the behaviour and its consequences, the so-called "Sense of Agency" (SoA), is a crucial component of self-awareness. One key aspect is the distinction from a mere inference about the causality between an act and its consequences and the sense of being the agent of it. Despite a large number of behavioural studies, there is unsatisfactory evidence on the functional anatomical underpinnings of the SoA and the distinction between causality and the SoA proper. Here, the investigators use an implicit measurement of the SoA and its modulations during fMRI: the intentional binding phenomenon (IB). The ivestigators also study how the SoA and the ensuing neurophysiological correlates are modulated by the presence of a movement disorders, such as Gilles de la Tourette Syndrome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Behavioral and fMRI |
| Patients with Gilles de la Tourette Syndrome | – | Other: Behavioral and fMRI |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy controls and patients with Gilles de la Tourette Syndrome
Key inclusion criteria (3 listed)
- Age included between 18 and 65 years
- Right handed
- No contraindication to the fMRI exam
Key exclusion criteria (1 listed)
- Contraindication to the fMRI exam
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 |
|---|---|---|
| Behavioral and fMRISubjects and patients will perform temporal-judgment-tasks (considered an indirect measure of the sense of agency) in an event-related fMRI setting. In the first task, they will hear a sound either caused by a voluntary key press or by the passive displacement of the same finger by the experimenter. Following each trial, subjects will estimate the delay between the finger movement and the subsequent sound, which will be presented at variable latencies after the key press. There will be also control-trials characterized by the active or passive movement with a subsequent sound presented with a delay that excludes causality inferences. | Other | Healthy subjects, Patients with Gilles de la Tourette Syndrome |
Primary outcome
BOLD signal changes
Time frame: April 2017 - October 2019
The investigators will measure the changes of the BOLD signal associated with the modification of the sense of agency both in healthy subjects and neurological patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: No
Related trials for Motor Activity
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Active, not recruiting
A Pilot Factorial Trial of an Integrated Lifestyle Intervention
Physical Inactivity, Overweight and Obesity
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Not yet recruiting
Planning Actions for Consistent Engagement
Physical Activity, Cognition
Recruiting
Comparıson of the Effıcacy of Conventıonal Exercıse and Pılates ın Pre-fraıl and Fraıl Older Adults
Frailty Syndrome, Prefrail Elderly
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.
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 Motor Activity and Motor Tic Disorders, 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Dec 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Zacchetti (+390266214057, sara.zacchetti@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal changes (time frame: April 2017 - October 2019). 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 5 Dec 2017; AzTrials last refreshed its copy on 7 Nov 2026.