Back to resultsUse of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease (COMPARE)
Primary Purpose
Parkinson Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
BART-EEG at V1 + V2
BART-EEG at V1 only
Sponsored by
About this trial
This is an interventional other trial for Parkinson Disease
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: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients
Control
Arm Description
Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists
Risky behaviors assessed through BART-EEG among healthy volunteers
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05640986
First Posted
November 29, 2022
Last Updated
December 8, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT05640986
Brief Title
Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease
Acronym
COMPARE
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2, 2023 (Anticipated)
Primary Completion Date
April 2, 2026 (Anticipated)
Study Completion Date
April 2, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Arm Description
Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Risky behaviors assessed through BART-EEG among healthy volunteers
Intervention Type
Behavioral
Intervention Name(s)
BART-EEG at V1 + V2
Intervention Description
Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 + V2 for Parkinsonian patients
Intervention Type
Behavioral
Intervention Name(s)
BART-EEG at V1 only
Intervention Description
Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 only for healthy volunteers
Primary Outcome Measure Information:
Title
Area under curve for dopaminergic agonist treatment
Description
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
Time Frame
Month 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu BEREAU, MD
Phone
0033381668248
Email
mbereau@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu BEREAU, MD
Organizational Affiliation
CHU de Besançon
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease
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