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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05640986
Acronym
COMPARE
Enrollment
80
Registered
2022-12-07
Start date
2023-01-02
Completion date
2026-04-02
Last updated
2022-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

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.

Interventions

BEHAVIORALBART-EEG at V1 + V2

Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 + V2 for Parkinsonian patients

BEHAVIORALBART-EEG at V1 only

Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 only for healthy volunteers

Sponsors

Centre Hospitalier Universitaire de Besancon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Area under curve for dopaminergic agonist treatmentMonth 9Area 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

Contacts

Primary ContactMatthieu BEREAU, MD
mbereau@chu-besancon.fr0033381668248

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026