Video-oculography and Parkinson's Disease: A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline of Oculomotor raw performance at 7 years - Gain in Vertical saccades.
研究概览
简要总结
This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015):
- the evolution of oculomotricity markers over time.
- the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years.
- the impact of antiparkinsonian drugs on the evolution of oculomotricity assessment by video-oculography.
- the value of oculomotricity assessment by video-oculography as an evolutionary marker of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •*Inclusion Criteria:
- •Male or Female;
- •Clinically defined idiopathic Parkinson's Disease (PD);
- •Brain MRI performed in routine care in the 12 months preceding inclusion;
- •Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation;
- •Hoehn & Yahr score: 1 to 3;
- •Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted);
- •Neuro-cognitive disorders: absent or minor (according to DSM5);
- •Sufficient written and oral expression in French;
- •Covered by a health insurance system;
- •Written informed consent signed by the patient;
- •Presence of a caregiver.
排除标准
- •Psychiatric comorbidity (except anxiety or mild to moderate depression);
- •Neurological comorbidity, if significant;
- •Brain MRI showing:
- •significant cerebrovascular pathology (Fazekas I admitted),
- •another brain disease, including stroke.
- •Major cognitive impairment;
- •Absolute exclusion criteria and "Red flags" of the 2015 criteria orienting towards another degenerative pathology of the extrapyramidal system:
- •Cerebellar syndrome
- •Vertical oculomotricity disorders on clinical examination
- •Motor symptoms restricted to the lower limbs
- •Bilateral and perfectly symmetrical parkinsonism
- •Early dystonia
- •Clinical profile suggestive of behavioral variant frontotemporal dementia (bvFTD)
- •Progressive aphasia or apraxia
- •Moderate or severe postural instability and / or early falls
- •Early bulbar dysfunction (dysarthria, swallowing disorders)
- •Ventilatory dysfunction (inspiration)
- •Severe dysautonomia
- •DOPA-resistance
- •Neuroleptic treatment or related
- •Normal MIBG myocardial scintigraphy (if performed).
结局指标
主要结局
Change from Baseline of Oculomotor raw performance at 7 years - Gain in Vertical saccades.
时间窗: Baseline; Year 7
This concerns saccades Gain (gaze accuracy) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Horizontal saccades.
时间窗: Baseline; Year 7
This concerns saccades Latency (in ms) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.
Change from Baseline of Oculomotor raw performance at 7 years - Gain in Horizontal saccades.
时间窗: Baseline; Year 7
This concerns saccades Gain (gaze accuracy) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.
Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Vertical saccades.
时间窗: Baseline; Year 7
This concerns saccades Main velocity (in °/sec) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.
Change from Baseline of Inhibition capacity at 7 years
时间窗: Baseline; Year 7
Measure of inhibition capacity performance during an "antisaccades" paradigm. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: percentage of errors. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.
Change from Baseline of Fixations impairments detection at 7 years
时间窗: Baseline; Year 7
Highlight presence/absence of Fixations impairments. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: presence/absence/frequency of square wave-jerks, nystagmus, flutters.
Change from Baseline of Internuclear ophthalmoplegia (INO) detection at 7 years
时间窗: Baseline; Year 7
Highlight presence/absence of INO. Eye movements were recorded and analyzed with an eye-tracking device. Evaluation criteria: INO is present if calculated ratio of abducting to adducting eye movement (both mean and peak velocity) is \>1.
Change from Baseline of Oculomotor raw performance at 7 years - Main velocity in Horizontal saccades.
时间窗: Baseline; Year 7
This concerns saccades Main velocity (in °/sec) during horizontal paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.
Change from Baseline of Oculomotor raw performance at 7 years - Latency in Vertical saccades.
时间窗: Baseline; Year 7
This concerns saccades Latency (in ms) during vertical paradigms. Eye movements were recorded and analyzed with an eye-tracking device. For each subject value were judged abnormal if they differed by \>1.65 SD compared to their reference sample.
次要结局
- Treatments of Parkinson's disease(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Evolution of Oculomotor raw performance - Latency in Vertical saccades(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Neurological evaluation - evolution of motor disorders(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS)(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Orthostatic hypotension(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Evolution of Oculomotor raw performance - Latency in Horizontal saccades(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Neurological evaluation - Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Patients description(Baseline)
- Internuclear ophthalmoplegia (INO) detection(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Fixations impairments detection(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Neurological evaluation - Movement Disorder Society Non-Motor rating Scale (MDS-NMS) Non-Motor Fluctuations (NMF)(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- DAT scan(Baseline; Year 3; Year 7)
- Evolution of Oculomotor raw performance - Main velocity in Horizontal saccades.(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Evolution of Oculomotor raw performance - Gain in Horizontal saccades.(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Evolution of Oculomotor raw performance - Gain in Vertical saccades(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Evolution of Oculomotor raw performance - Main velocity in Vertical saccades(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Inhibition capacity(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7: before and after first PD treatment introduction if applicable)
- Executive performance - Stroop test(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Executive performance - B.R.E.F.(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Verbal fluency(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Visuospatial function(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- PET/CT scan(Baseline; Year 3; Year 7)
- MIBG myocardial scintigraphy(Baseline; Year 3; Year 7)
- MRI scan(Baseline; Year 3; Year 7)
- Mini Mental State (MMSE)(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Visuospatial/constructional ability(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Evolution of general cognitive behavior(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Executive performance - T.M.T(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Praxis assessment(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Episodic memory performance(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)
- Social cognition and Emotional assessment(Baseline; Year 1; Year 2; Year 3; Year 4; Year 5; Year 6; Year 7)