Clinical trial NCT05640986: Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease
Official title: Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-12-07
Enrollment: 80
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 criteria
* Parkinson disease appeared ≤ 60 years old
* Disease evolving since ≥ 5 years
* Daily dose for du dopaminergic treatment ≥ 200mg/day DOPA equivalent
* Patients requiring in routine care the introduction or increase of dopaminergic agonists treatment because of:

  1. HYPOdopaminergic behavioral syndrome \[TYPO\] including apathy, anxiety, depression and/or
  2. motor syndrome insufficiently controlled by dopaminergic treatment (akinesia, rigidity, tremor)

Exclusion Criteria:

* Cognitive disorders (Montreal Cognitive Assessment \[MoCA\] \< 25/30)
* Parkinson disease psychosis
* HYPERdopaminergic behavioral disorders \[TYPER\] defined by a score ≥ 2 at at least 1 item of HYPERdopaminergic behavioral spectrum of Parkinson disease
* Contraindications for dopaminergic agonists
* Patient treated with deep brain stimulation
* Serious 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 treatment
* Pregnant or breastfeeding women

Primary outcomes:
measure: Area under curve for dopaminergic agonist treatment
timeFrame: Month 9
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Besançon
name: Matthieu BEREAU, MD
role: PRINCIPAL_INVESTIGATOR
References: