Social Perception and Dopaminergic Modulation in Patients With Parkinson's Disease: a Functional MRI Study (Park Social-E-Motion)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Stage 1: PD patients
20 adult patients with Parkinson disease will perform a behavioral task of social perception.
干预措施: Behavioral task of social perception (stage 1) (Behavioral)
Stage 1: PD patients
20 adult patients with Parkinson disease will perform a behavioral task of social perception.
干预措施: Neurological and neuropsychological assessments (Other)
Stage 1: PD patients
20 adult patients with Parkinson disease will perform a behavioral task of social perception.
干预措施: Neurological assessments of Parkinson's disease symptoms and caregiver burden (Other)
Stage 1: healthy volunteers
20 adult patients without neurologic disorders will perform a behavioral task of social perception.
干预措施: Behavioral task of social perception (stage 1) (Behavioral)
Stage 1: healthy volunteers
20 adult patients without neurologic disorders will perform a behavioral task of social perception.
干预措施: Neurological and neuropsychological assessments (Other)
Stage 2: PD patients
23 adult patients with Parkinson disease will perform a behavioral task of social perception during functional MRI recording.
干预措施: Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2) (Other)
Stage 2: PD patients
23 adult patients with Parkinson disease will perform a behavioral task of social perception during functional MRI recording.
干预措施: Neurological and neuropsychological assessments (Other)
Stage 2: PD patients
23 adult patients with Parkinson disease will perform a behavioral task of social perception during functional MRI recording.
干预措施: Neurological assessments of Parkinson's disease symptoms and caregiver burden (Other)
Stage 2: healthy volunteers
20 adult volunteers without neurologic disorder will perform a behavioral task of social perception during functional MRI recording
干预措施: Functional magnetic resonance imaging: 3 Tesla magnetic resonance imaging (stage 2) (Other)
Stage 2: healthy volunteers
20 adult volunteers without neurologic disorder will perform a behavioral task of social perception during functional MRI recording
干预措施: Neurological and neuropsychological assessments (Other)
结局指标
主要结局
BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers
时间窗: 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
次要结局
- 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(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(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(Up to 75 days)
- Group correlation between clinical and neuropsychological scores and BOLD signal difference in patients with Parkinson's disease(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(Up to 75 days)