How people with Parkinson's disease perceive social cues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.