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

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease
• Interventions: Behavioral: BART-EEG at V1 + V2; Behavioral: BART-EEG at V1 only

• Registration Number: NCT05640986
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Status Verified: 2022-12
• Study First Posted: 2022-12-07
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12
• Study Start: 2023-01-02
• Primary Completion: 2026-04-02
• Study Completion: 2026-04-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients	BART-EEG at V1 + V2	Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists
Control	BART-EEG at V1 only	Risky behaviors assessed through BART-EEG among healthy volunteers

Primary Outcome Measures

Name	Time	Method
Area under curve for dopaminergic agonist treatment	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