Use of BART Coupled With EEG in the Early Diagnosis of Behavioral Disorders in Parkinson's Disease: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Area under curve for dopaminergic agonist treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Area under curve for dopaminergic agonist treatment
时间窗: 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
次要结局
未报告次要终点