Brain Mechanisms of Social Perception in Parkinson's Disease

NCT ID: NCT06884722

Last Updated: 2025-07-22

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2027-04-30

Brief Summary

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Social cognition is a complex process that enables humans to interpret social information and behave appropriately in a social environment. Social cognition can be impaired in Parkinson's disease patients, worsening quality of life and relationships with those around them, even at an early stage. These alterations are manifested in particular by impairments of the recognition of facial emotions and body movements, involving the motor system. The aim of this study is to understand the brain mechanisms associated with impaired social perception in people with Parkinson's disease using functional MRI and a behavioural task for the perception of social interaction scenes depicted by "Point Light Display" (PLD).This study will investigate the effect of dopaminergic modulation on the networks associated with the perception of movement and mirror system, the observation of action (parietal cortex, superior temporal sulcus), and those associated with the mentalization of others' cognitive or emotional states (prefrontal cortex and limbic system).

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

Detailed Description

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Conditions

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Social Perception in Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

For patients: one MRI scan in the OFF dopaminergic treatment condition and one MRI scan in the ON dopaminergic treatment condition (randomized order by block).

For controls: one MRI scan.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

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.

Group Type OTHER

Behavioral task of social perception (stage 1)

Intervention Type BEHAVIORAL

Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task.

Neurological and neuropsychological assessments

Intervention Type OTHER

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

Intervention Type OTHER

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.

Group Type OTHER

Behavioral task of social perception (stage 1)

Intervention Type BEHAVIORAL

Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task.

Neurological and neuropsychological assessments

Intervention Type OTHER

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.

Group Type OTHER

Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2)

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Group Type OTHER

Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2)

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type BEHAVIORAL

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

Intervention Type OTHER

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).

Intervention Type OTHER

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).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female between 30 and 75 years of age
* 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

* Contraindication to MRI (only for patients and healthy volunteers in step 2 "imaging"):

* 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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service de neurologie - troubles du mouvement et pathologies neuromusculaires, Hôpital neurologique Pierre Wertheimer/GHE

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stéphane PRANGE, MD, PhD

Role: CONTACT

472 357 222 ext. +33

Elise METEREAU

Role: CONTACT

427 856 208 ext. +33

Facility Contacts

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Stéphane PRANGE, MD, PhD

Role: primary

472 357 222 ext. +33

Other Identifiers

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69HCL24_0681

Identifier Type: -

Identifier Source: org_study_id

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