ClinicalTrials.gg
Status unknownNCT03361332SOAUpdated Dec 5, 2017

The Sense of Agency

An observational study in Motor Activity and Motor Tic Disorders, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-12-05.

Primary conditionTic DisordersRegistry: Motor ActivityReclassifiedWhy we changed it
Registry
Motor Activity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Tic Disorders
Why
  1. Motor Activity is a broad heading, used only when no more specific condition is named.
  2. The study's listed conditions name Tic Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Motor Activity
  • Motor Tic Disorders

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03

In context

Tic Disorders Reclassified

102 studies on the registry are indexed under Tic Disorders; 26 are open to participants now.

This study's planned enrollment of 50 is close to the median of 54 across 17 observational studies indexed under Tic Disorders.

Browse Tic Disorders studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 160 studies on the registry; 59 are open to participants now.

Compared within Tic Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Motor Activity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Healthy controls and patients with Gilles de la Tourette Syndrome

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age included between 18 and 65 years
  • Right handed
  • No to the fMRI exam

Exclusion criteria

Exclusion Criteria:

  • to the fMRI exam
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Healthy subjects

    Other: Behavioral and fMRI

  • Patients with Gilles de la Tourette Syndrome

    Other: Behavioral and fMRI

Interventions

  • OtherBehavioral and fMRI

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: April 2017 - October 2019

07

Study locations

1 of 1 sites recruiting
  • IRCCS Galeazzi Orthopedic Hospital
    Milan, 20161, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2017 to primary completion in Jul 2017, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2017
First posted
Dec 4, 2017
StartActual
Apr 8, 2017
Primary completionActual
Jul 29, 2017
CompletionEst.
Jan 23, 2020
Last update
Dec 5, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03361332
Responsible party
Sponsor
First posted
Dec 4, 2017
Start date
Apr 8, 2017
Primary completion
Jul 29, 2017
Completion
Jan 23, 2020 (estimated)
Last update
Dec 5, 2017

Study contacts

Sara Zacchetti
Contact
sara.zacchetti@grupposandonato.it
+390266214057

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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