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Not Yet Recruiting NCT05640986

Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease

Conditions: Parkinson Disease

Sex: All
Ages: 25 Years – 70 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 80
Sponsor: Centre Hospitalier Universitaire de Besancon

Summary

The Balloon Analogue Risk Task [BART] is an experimental task modelizing risky behaviors. In Parkinson disease, the correlation between BART and modifications of cerebral activity in ventral striatum has been shown. BART thus seems to be particularly adapted for modelization of HYPERdopaminergic behavioral disorders [TYPER] into Parkinsonian patients. Previously, a version of the BART performed with EEG has been specifically developped by the Centre d'Investigation Clinique of Besançon University Hospital, in collaboration with the Clinical and integrative neurosciences laboratory. Preliminary data suggest that the analysis of evoked potentials including Feedback-related Negativity [FRN], P300 wave, and Reward Positivity [RewP], could help assessing the motivational and attentional attributes of decision making and the delayed treatment of any reward.The hypothesis of the study that the EEG version of the BART could help predicting the risk to develop TYPER into Parkinsonian patients treated by dopaminergic in routine care.

Eligibility Criteria

Inclusion Criteria:Probable Diagnosis of Parkinson's disease according to the Movement Disorder Society criteriaParkinson disease appeared ≤ 60 years oldDisease evolving since ≥ 5 yearsDaily dose for du dopaminergic treatment ≥ 200mg/day DOPA equivalentPatients requiring in routine care the introduction or increase of dopaminergic agonists treatment because of:HYPOdopaminergic behavioral syndrome [TYPO] including apathy, anxiety, depression and/ormotor syndrome insufficiently controlled by dopaminergic treatment (akinesia, rigidity, tremor)Exclusion Criteria:Cognitive disorders (Montreal Cognitive Assessment [MoCA] < 25/30)Parkinson disease psychosisHYPERdopaminergic behavioral disorders [TYPER] defined by a score ≥ 2 at at least 1 item of HYPERdopaminergic behavioral spectrum of Parkinson diseaseContraindications for dopaminergic agonistsPatient treated with deep brain stimulationSerious psychiatric comorbidity (major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders [DSM] V criteria, suicidal patient, other active psychosis, etc.)Unstabilized psychotropic treatmentPregnant or breastfeeding women

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Source: ClinicalTrials.gov (NCT05640986). StuddyBuddy aggregates publicly available trial information.