Brain Mechanisms of Social Perception in Parkinson's Disease

Официальное название

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

Обзор

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

Вмешательства

• Поведенческое Behavioral task of social perception (stage 1)
  Patients with Parkinson disease and healthy volunteer are engaged in a social perception behavioral task.
• Другое 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
• Другое 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).
• Другое 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).

Первичные конечные точки

• BOLD signal difference in the brain networks associated with social perception in Parkinson's patients compared with age- and sex-matched healthy volunteers [Срок оценки: Up to 75 days]

Вторичные конечные точки (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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Up to 75 days]
• Group correlation between clinical and neuropsychological scores and BOLD signal difference in patients with Parkinson's disease [Срок оценки: 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 [Срок оценки: Up to 75 days]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 1 центр

• Service de neurologie - troubles du mouvement et pathologies neuromusculaires, Hôpital neu — Bron

Идентификаторы

NCT: NCT06884722 · 69HCL24_0681

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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