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

NCT ID: NCT05640986

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2026-04-02

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients

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

Group Type EXPERIMENTAL

BART-EEG at V1 + V2

Intervention Type BEHAVIORAL

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

Control

Risky behaviors assessed through BART-EEG among healthy volunteers

Group Type ACTIVE_COMPARATOR

BART-EEG at V1 only

Intervention Type BEHAVIORAL

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

Interventions

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BART-EEG at V1 + V2

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

Intervention Type BEHAVIORAL

BART-EEG at V1 only

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthieu BEREAU, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Besançon

Central Contacts

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Matthieu BEREAU, MD

Role: CONTACT

Phone: 0033381668248

Email: [email protected]

Other Identifiers

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2021/615

Identifier Type: -

Identifier Source: org_study_id