Brain Mechanisms of Social Perception in Parkinson's Disease (Park Social)

Social Perception and Dopaminergic Modulation in Patients With Parkinson's Disease: a Functional MRI Study (Park Social-E-Motion)

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

Study Overview

• Status: Recruiting
• Conditions: Social Perception in Parkinson's Disease
• Intervention / Treatment: Behavioral: Behavioral task of social perception (stage 1); Other: Neurological and neuropsychological assessments; Other: Neurological assessments of Parkinson's disease symptoms and caregiver burden; Other: Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2)

• Study Type: Interventional
• Enrollment (Estimated): 83
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stéphane PRANGE, MD, PhD; Phone Number: +33 472 357 222; Email: stephane.prange@chu-lyon.fr
• Study Contact Backup: Name: Elise METEREAU; Phone Number: +33 427 856 208; Email: elise.metereau@chu-lyon.fr

Study Locations

• France
  • Bron, France, 69677
    • Recruiting
    • Service de neurologie - troubles du mouvement et pathologies neuromusculaires, Hôpital neurologique Pierre Wertheimer/GHE
    • Contact: Stéphane PRANGE, MD, PhD; Phone Number: +33 472 357 222; Email: stephane.prange@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stage 1: PD patients; 20 adult patients with Parkinson disease will perform a behavioral task of social perception.	Behavioral: Behavioral task of social perception (stage 1); Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task.; 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).; 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).
Other: Stage 1: healthy volunteers; 20 adult patients without neurologic disorders will perform a behavioral task of social perception.	Behavioral: Behavioral task of social perception (stage 1); Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task.; 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).
Other: Stage 2: PD patients; 23 adult patients with Parkinson disease will perform a behavioral task of social perception during functional MRI recording.	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).; 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).; Other: 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
Other: Stage 2: healthy volunteers; 20 adult volunteers without neurologic disorder will perform a behavioral task of social perception during functional MRI recording	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).; Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers	BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers during a social perception behavioural task using point light display	Up to 75 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers for the emotional valence	BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers during a social perception behavioural task using point light display with emotional content	Up to 75 days
BOLD signal difference in the brain networks associated with social perception in Parkinson's patients in the OFF versus ON dopaminergic treatment conditions	BOLD signal difference in the brain networks associated with social perception in Parkinson's patients during a social perception behavioural task using point light display in the OFF versus ON dopaminergic treatment conditions	Up to 75 days
BOLD signal difference in the brain networks associated with social perception in Parkinson's patients in the emotional content and OFF versus ON dopaminergic treatment conditions	BOLD signal difference in the brain networks associated with social perception in Parkinson's patients during a social perception behavioural task using point light display for the emotional content and the OFF versus ON dopaminergic treatment conditions	Up to 75 days
Group correlation between clinical and neuropsychological scores and BOLD signal difference in patients with Parkinson's disease	Group correlation between clinical and neuropsychological scores and BOLD signal difference in the brain networks associated with social perception in Parkinson's patients during a social perception behavioural task using point light display for the emotional content and the OFF versus ON dopaminergic treatment conditions	Up to 75 days
Group correlation between the integrity of substantia nigra and locus coeruleus nuclei measured on anatomical MRI and the BOLD signal difference in the brain networks associated with social perception in Parkinson's patients	Group correlation between the integrity of substantia nigra and locus coeruleus nuclei measured on anatomical MRI and the BOLD signal difference in the brain networks associated with social perception in Parkinson's patients during a social perception behavioural task using point light display	Up to 75 days

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Parkinson's disease; Social Cognition; Functional MRI; Point light display
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 69HCL24_0681

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No