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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05640986

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Behavioral: BART-EEG at V1 + V2 Behavioral: BART-EEG at V1 only	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Apr 2, 2026

Anticipated Study Completion Date :

Apr 2, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists	Behavioral: BART-EEG at V1 + V2 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	Behavioral: BART-EEG at V1 only Balloon Analogue Risk Task coupled to Electroencephalogram (BART-EEG) at V1 only for healthy volunteers

Arm

Intervention/Treatment

Experimental: Patients

Risky behaviors assessed through BART-EEG among Parkinsonian patients newly treated with dopaminergic agonists

Behavioral: BART-EEG at V1 + V2

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

Behavioral: BART-EEG at V1 only

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

Principal Investigator: Matthieu BEREAU, MD, CHU de Besançon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT05640986

Other Study ID Numbers:

2021/615

First Posted:

Dec 7, 2022

Last Update Posted:

Dec 12, 2022

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Dec 12, 2022