How people with Parkinson's disease perceive social cues
Social Perception and Dopaminergic Modulation in Patients With Parkinson's Disease: a Functional MRI Study (Park Social-E-Motion)
This trial tries to see if dopaminergic medication changes brain activity during social perception tasks in people with Parkinson's disease using a behavioral point-light display task and 3T fMRI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 83 (estimated) |
| Ages | 30 Years to 75 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT06884722 on ClinicalTrials.gov |
What this trial studies
This interventional study enrolls people with Parkinson's disease who have been on dopaminergic treatment for at least three years and who have preserved global cognition. Participants complete a behavioral task using point-light displays of social interactions and undergo 3 Tesla functional MRI to map networks involved in movement perception, action observation, and mentalizing. The protocol includes neurological and neuropsychological assessments and examines the effect of dopaminergic modulation on those networks (for the imaging stage). Data will be used to relate task performance to activity in motor, parietal, and superior temporal sulcus regions implicated in social cognition.
Who should consider this trial
Good fit: Ideal candidates are men or women age 30–75 with a Parkinson's diagnosis for at least three years who are on dopaminergic treatment, have MoCA ≥ 26, can give informed consent, and can attend imaging visits including standard dopa testing.
Not a fit: People with disabling chronic diseases, significant cognitive impairment (MoCA < 26), contraindications to MRI, or who are not receiving dopaminergic therapy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could clarify why social perception is impaired in Parkinson's and guide medication or behavioural approaches to improve social functioning and relationships.
How similar studies have performed: Previous research has demonstrated altered social cognition and related brain activation in Parkinson's disease, but using point-light displays with dopaminergic modulation and 3T fMRI is a relatively novel combination.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bron
- Service de neurologie - troubles du mouvement et pathologies neuromusculaires, Hôpital neurologique Pierre Wertheimer/GHE — Bron, France (Recruiting)
Study contacts
- Study coordinator: Stéphane PRANGE, MD, PhD
- Email: stephane.prange@chu-lyon.fr
- Phone: 472 357 222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.