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

Parkinson Disease Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05640986
• Other study ID #: 2021/615
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2, 2023
• Est. completion date: April 2, 2026

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Matthieu BEREAU, MD
• Phone: 0033381668248
• Email: mbereau[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2, 2026
• Est. primary completion date: April 2, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• BART-EEG at V1 + V2
Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 + V2 for Parkinsonian patients
• BART-EEG at V1 only
Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 only for healthy volunteers

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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