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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03361332
Other study ID # SOA
Secondary ID
Status Recruiting
Phase N/A
First received November 28, 2017
Last updated December 4, 2017
Start date April 8, 2017
Est. completion date January 23, 2020

Study information

Verified date December 2017
Source Istituto Ortopedico Galeazzi
Contact Sara Zacchetti
Phone +390266214057
Email sara.zacchetti@grupposandonato.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 23, 2020
Est. primary completion date July 29, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Age included between 18 and 65 years

- Right handed

- No contraindication to the fMRI exam

Exclusion Criteria:

- Contraindication to the fMRI exam

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Behavioral 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.

Locations

Country Name City State
Italy IRCCS Galeazzi Orthopedic Hospital Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. April 2017 - October 2019
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