Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease (COMPARE)
Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease: a Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Matthieu BEREAU, MD
- Phone Number: 0033381668248
- Email: mbereau@chu-besancon.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients
Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists
|
Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 + V2 for Parkinsonian patients
|
|
Active Comparator: Control
Risky behaviors assessed through BART-EEG among healthy volunteers
|
Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 only for healthy volunteers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area under curve for dopaminergic agonist treatment
Time Frame: Month 9
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Matthieu Béreau, MD, CHU de Besançon
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/615
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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