Social Perception in Parkinson's DiseasePark SocialNCT06884722
Brain Mechanisms of Social Perception in Parkinson's Disease
A study testing Behavioral task of social perception (stage 1), Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2) and Neurological and neuropsychological assessments in people with Social Perception in Parkinson's Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Perception in Parkinson's Disease
- What is being tested?
- Behavioral task of social perception (stage 1), Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2) and Neurological and neuropsychological assessments
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2025to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de neurologie - troubles du mouvement et pathologies neuromusculaires, Hôpital neurologique Pierre Wertheimer/GHE
Bron, 69677
Stéphane PRANGE, MD, PhD, 472 357 222 ext. +33, stephane.prange@chu-lyon.fr
About this study
Official title: 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
- Conditions
- Social Perception in Parkinson's Disease
- Being tested
- Behavioral task of social perception (stage 1), Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2), Neurological and neuropsychological assessments, Neurological assessments of Parkinson's disease symptoms and caregiver burden
- Keywords
- Functional MRI, Parkinson's disease, Social Cognition, Point light display
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral task of social perception (stage 1)Behavioural
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)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 assessmentsOther
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 burdenOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: PD patients | Other | 20 adult patients with Parkinson disease will perform a behavioral task of social perception. Receives: Behavioral: Behavioral task of social perception (stage 1); Other: Neurological and neuropsychological assessments; Other: Neurological assessments of Parkinson's disease symptoms and caregiver burden |
| Stage 1: healthy volunteers | Other | 20 adult patients without neurologic disorders will perform a behavioral task of social perception. Receives: Behavioral: Behavioral task of social perception (stage 1); Other: Neurological and neuropsychological assessments |
| Stage 2: PD patients | Other | 23 adult patients with Parkinson disease will perform a behavioral task of social perception during functional MRI recording. Receives: Other: Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2); Other: Neurological and neuropsychological assessments; Other: Neurological assessments of Parkinson's disease symptoms and caregiver burden |
| Stage 2: healthy volunteers | Other | 20 adult volunteers without neurologic disorder will perform a behavioral task of social perception during functional MRI recording Receives: Other: Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2); Other: Neurological and neuropsychological assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 75 days
Secondary outcomes (5)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Jul 2025
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Perception in Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 83 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884722
- Sponsor's protocol ID
- 69HCL24_0681
- Acronym
- Park Social
- Status last verified
- Jul 2025
- First submitted
- 7 Mar 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Perception and Dopaminergic Modulation in Patients With Parkinson's Disease: a Functional MRI Study (Park Social-E-Motion)
- ClinicalTrials.gov ID
- NCT06884722
- Acronym / sponsor ID
- Park Social / 69HCL24_0681
- Conditions
- Social Perception in Parkinson's Disease
- Keywords
- Functional MRI, Parkinson's disease, Social Cognition, Point light display
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 83 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Stage 1: PD patients | Other | Behavioral: Behavioral task of social perception (stage 1), Other: Neurological and neuropsychological assessments, Other: Neurological assessments of Parkinson's disease symptoms and caregiver burden20 adult patients with Parkinson disease will perform a behavioral task of social perception. |
| Stage 1: healthy volunteers | Other | Behavioral: Behavioral task of social perception (stage 1), Other: Neurological and neuropsychological assessments20 adult patients without neurologic disorders will perform a behavioral task of social perception. |
| Stage 2: PD patients | Other | Other: Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2), Other: Neurological and neuropsychological assessments, Other: Neurological assessments of Parkinson's disease symptoms and caregiver burden23 adult patients with Parkinson disease will perform a behavioral task of social perception during functional MRI recording. |
| Stage 2: healthy volunteers | Other | Other: Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2), Other: Neurological and neuropsychological assessments20 adult volunteers without neurologic disorder will perform a behavioral task of social perception during functional MRI recording |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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")
Key exclusion criteria (16 listed)
- Contraindication to MRI (only for patients and healthy volunteers in step 2 "imaging"):
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral task of social perception (stage 1)Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task. | Behavioural | Stage 1: PD patients, Stage 1: healthy volunteers |
| 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: PD patients, Stage 2: healthy volunteers |
| Neurological and neuropsychological assessmentsPatients 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 1: PD patients, Stage 1: healthy volunteers, Stage 2: PD patients, Stage 2: healthy volunteers |
| Neurological assessments of Parkinson's disease symptoms and caregiver burdenPatients 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: PD patients, Stage 2: PD patients |
Primary outcome
BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers
Time frame: Up to 75 days
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
5 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: Up to 75 days
Group correlation between clinical and neuropsychological scores and BOLD signal difference in patients with Parkinson's disease
Time frame: 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
Time frame: Up to 75 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral task of social perception (stage 1), Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2) and Neurological and neuropsychological assessments in people with Social Perception in Parkinson's Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphane PRANGE, MD, PhD (472 357 222 ext. +33, stephane.prange@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers (time frame: Up to 75 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.