Brain Mechanisms of Social Perception in Parkinson's Disease
NCT ID: NCT06884722
Last Updated: 2025-07-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
83 participants
INTERVENTIONAL
2025-07-15
2027-04-30
Brief Summary
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The study is thus divided into 2 stages.
* Stage 1 "preliminary": Preliminary validation of the experimental task
* Stage 2 "imagery": Assessment of brain activity (BOLD signal) related to social perception in imaging
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
For controls: one MRI scan.
BASIC_SCIENCE
NONE
Study Groups
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Stage 1: PD patients
20 adult patients with Parkinson disease will perform a behavioral task of social perception.
Behavioral task of social perception (stage 1)
Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task.
Neurological and neuropsychological assessments
Patients with Parkinson disease and healthy volunteer will undergo a neurological and neuropsychological assessment with several evaluations: weight, height, medical history, global cognitive performance (MoCA and BREF score), apathy (LARS score), depression (BDI-II score), social cognition (mini-SEA), and quality of life (PDQ39 self-questionnaire).
Neurological assessments of Parkinson's disease symptoms and caregiver burden
Patients with Parkinson disease will undergo a neurological assessment of motor and non-motor symptoms of Parkinson's disease (MDS-UPDRS III \& IV scale and MDS-NMS scale) and caregiver burden (Zarit scale).
Stage 1: healthy volunteers
20 adult patients without neurologic disorders will perform a behavioral task of social perception.
Behavioral task of social perception (stage 1)
Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task.
Neurological and neuropsychological assessments
Patients with Parkinson disease and healthy volunteer will undergo a neurological and neuropsychological assessment with several evaluations: weight, height, medical history, global cognitive performance (MoCA and BREF score), apathy (LARS score), depression (BDI-II score), social cognition (mini-SEA), and quality of life (PDQ39 self-questionnaire).
Stage 2: PD patients
23 adult patients with Parkinson disease will perform a behavioral task of social perception during functional MRI recording.
Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2)
Patients with Parkinson disease and healthy volunteer are assessed by functional magnetic resonance imaging while they are engaged in a social perception behavioral task.
2 times for patients with Parkinson disease (during ON-levodopa and OFF-levodopa) Once for healthy volunteer
Neurological and neuropsychological assessments
Patients with Parkinson disease and healthy volunteer will undergo a neurological and neuropsychological assessment with several evaluations: weight, height, medical history, global cognitive performance (MoCA and BREF score), apathy (LARS score), depression (BDI-II score), social cognition (mini-SEA), and quality of life (PDQ39 self-questionnaire).
Neurological assessments of Parkinson's disease symptoms and caregiver burden
Patients with Parkinson disease will undergo a neurological assessment of motor and non-motor symptoms of Parkinson's disease (MDS-UPDRS III \& IV scale and MDS-NMS scale) and caregiver burden (Zarit scale).
Stage 2: healthy volunteers
20 adult volunteers without neurologic disorder will perform a behavioral task of social perception during functional MRI recording
Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2)
Patients with Parkinson disease and healthy volunteer are assessed by functional magnetic resonance imaging while they are engaged in a social perception behavioral task.
2 times for patients with Parkinson disease (during ON-levodopa and OFF-levodopa) Once for healthy volunteer
Neurological and neuropsychological assessments
Patients with Parkinson disease and healthy volunteer will undergo a neurological and neuropsychological assessment with several evaluations: weight, height, medical history, global cognitive performance (MoCA and BREF score), apathy (LARS score), depression (BDI-II score), social cognition (mini-SEA), and quality of life (PDQ39 self-questionnaire).
Interventions
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Behavioral task of social perception (stage 1)
Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task.
Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2)
Patients with Parkinson disease and healthy volunteer are assessed by functional magnetic resonance imaging while they are engaged in a social perception behavioral task.
2 times for patients with Parkinson disease (during ON-levodopa and OFF-levodopa) Once for healthy volunteer
Neurological and neuropsychological assessments
Patients with Parkinson disease and healthy volunteer will undergo a neurological and neuropsychological assessment with several evaluations: weight, height, medical history, global cognitive performance (MoCA and BREF score), apathy (LARS score), depression (BDI-II score), social cognition (mini-SEA), and quality of life (PDQ39 self-questionnaire).
Neurological assessments of Parkinson's disease symptoms and caregiver burden
Patients with Parkinson disease will undergo a neurological assessment of motor and non-motor symptoms of Parkinson's disease (MDS-UPDRS III \& IV scale and MDS-NMS scale) and caregiver burden (Zarit scale).
Eligibility Criteria
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Inclusion Criteria
* Freely-given informed consent to participate to this study (written form)
* Affiliated with a social security system or equivalent;
* Person diagnosed with Parkinson's disease according to MDS-UPDRS criteria for at least 3 years and receiving dopaminergic treatment (e.g. : LEVODOPA, CARBIDOPA, BENZERASIDE, ENTACAPONE, MODOPAR, SINEMET, STALEVO, PRAMIPEXOLE, SIFROL, ROPINIROLE, REQUIP ; ROTIGOTINE, NEUPRO, PIRIBEDIL, TRIVASTAL, RASAGILINE, AZILECT, CONTAM, AMANTADINE, MANTADIX, APOMORPHINE, APOKINON, DOPACEPTIN, FOSLEVODOPA, FOSCARBIDOPA, SCYOVA) (for patients only)
* Effective contraception for women of childbearing age or post-menopausal women (only for patients and healthy volunteers in stage 2 "imaging")
* Requiring dopa testing as part of routine care (only for patients in stage 2 "imaging")
* No disabling cognitive impairment (MOCA score ≥ 26)
* No diagnosis of chronic disease associated with disability (only for healthy volunteers)
Exclusion Criteria
* Wearing a pacemaker not approved for 3 Tesla MRI
* Presence of intracerebral ferromagnetic or magnetizable material
* Presence of intraocular ferromagnetic or magnetizable foreign bodies
* Presence of non-removable ferro-magnetic or magnetizable foreign bodies in the cephalic region
* Claustrophobia
* History of head trauma with loss of consciousness lasting more than 30 min (only for patients and healthy volunteers in step 2 "imaging")
* Participant not agreeing to be informed in the event of incidental discovery of an abnormality on MRI (only for patients and healthy volunteers in stage 2 "imaging")
* Tremor or disabling dyskinesias preventing MRI (only for patients in stage 2)
* Having exceeded the annual amount of compensation allowed for participation in research protocols (only for healthy volunteers)
* Pregnant, parturient or breast-feeding women
* Persons deprived of liberty by judicial or administrative decision
* Persons under psychiatric care
* Persons admitted to a health or social institution for purposes other than research
* Adults under legal protection (guardianship, curatorship)
* Participants in other intervention research involving a period of exclusion still in progress at the time of pre-inclusion.
30 Years
75 Years
ALL
Yes
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Locations
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Service de neurologie - troubles du mouvement et pathologies neuromusculaires, Hôpital neurologique Pierre Wertheimer/GHE
Bron, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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69HCL24_0681
Identifier Type: -
Identifier Source: org_study_id
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