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

Study Overview
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Brief Summary
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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.

Official Title
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Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease: a Pilot Study

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: BART-EEG at V1 + V2
* Behavioral: BART-EEG at V1 only


Participation Criteria
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Eligibility Criteria
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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: HYPOdopaminergic behavioral syndrome [TYPO] including apathy, anxiety, depression and/or 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists | Behavioral: BART-EEG at V1 + V2<br>* Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 + V2 for Parkinsonian patients<br>|
| Active Comparator: Control<br>Risky behaviors assessed through BART-EEG among healthy volunteers | Behavioral: BART-EEG at V1 only<br>* Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 only for healthy volunteers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve for dopaminergic agonist treatment | Area Under the Curve / Receiver Operating Characteristic Curve [AUC-ROC] of [FRN] amplitude measured at baseline for TYPER risk 9 months after introduction or increase of dopaminergic agonist treatment | Month 9 |