- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03361332
The Sense of Agency (SOA)
December 4, 2017 updated by: Istituto Ortopedico Galeazzi
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Milan, Italy, 20161
- Recruiting
- IRCCS Galeazzi Orthopedic Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Healthy controls and patients with Gilles de la Tourette Syndrome
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy subjects
|
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.
|
Patients with Gilles de la Tourette Syndrome
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
April 2017 - October 2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 8, 2017
Primary Completion (ACTUAL)
July 29, 2017
Study Completion (ANTICIPATED)
January 23, 2020
Study Registration Dates
First Submitted
November 28, 2017
First Submitted That Met QC Criteria
December 1, 2017
First Posted (ACTUAL)
December 4, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 5, 2017
Last Update Submitted That Met QC Criteria
December 4, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Motor Activity
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)CompletedMotor Activity | Motor NeuroplasticityUnited States
-
Charles University, Czech RepublicRecruiting
-
Seattle Children's HospitalCompleted
-
Charles University, Czech RepublicActive, not recruiting
-
Riphah International UniversityCompleted
-
University of MichiganCompleted
-
University of TriesteCompleted
-
University Hospital, GrenobleUniversité Joseph Fourier; Centre National de la Recherche Scientifique, FranceCompleted
-
Rowe, Veronica, M.D.Completed
Clinical Trials on Behavioral and fMRI
-
University Hospital, GrenobleUnknownSchizophrenia | Bipolar DisorderFrance
-
KU LeuvenUnknownObsessive-Compulsive DisorderBelgium
-
Hospices Civils de LyonRecruitingHealthy | Visual ImpairmentFrance
-
Vanderbilt University Medical CenterVarian Medical SystemsRecruitingDepression | Obsessive-Compulsive Disorder | Pain, IntractableUnited States
-
Wyss Center for Bio and NeuroengineeringEcole Polytechnique Fédérale de LausanneCompleted
-
Yale UniversityEnrolling by invitationIntellectual Disability | AutismUnited States
-
Federal Research Center of Fundamental and Translational...CompletedDepression Moderate | Depression MildRussian Federation
-
Centre Hospitalier St AnneAssistance Publique - Hôpitaux de Paris; National Research Agency, France; CENIR... and other collaboratorsUnknown
-
University of MichiganNational Institute of Mental Health (NIMH)Completed