帕金森病的视觉空间和情感能力
帕金森病视觉空间和情感能力的评估和康复
The aim of the study is to investigate whether prismatic adaptation (PA) and virtual prismatic adaptation (VPA), a non-invasive neuromodulation technique, that involves the use of lenses that deviate the visual field, can modulate alexithyima and performance in visuospatial tasks in patients with Parkinson disease. Furthermore, brain activity during the prismatic adaptation and post-adaptation phases will be recorded using functional near-infrared spectroscopy (fNIRS) and high-density electroencephalography (HD-EEG). Based on these premises, the present project aims to investigate the deficits of the affective, motor and visuospatial abilities in Parkinson's patients and the modulation of disorders through prismatic adaptation (PA) and virtual prism adaptation (VPA). Finally, we would like to evaluate production of the tear film and correlate their quantity with the severity of PD as it could be proposed as a new, non-invasive biomarker.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Messina
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Messina、Messina、意大利、98124
- Laura Culicetto
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Over 18 years old;
- Right-handed;
- Diagnosis of idiopathic Parkinson's disease according to the UK Brain Bank criteria (Lyon and Pahwa, 2011);
- Hoehn and Yahr Stadium (Hoehn and Yahr, 1996) <2,5;
- Stable pharmacological treatment (dopaminergic therapy: dopamine agonists and Levo-dopa) in the last 6 weeks.
Exclusion Criteria:
- - Sensory-motor deficits that can hinder neuropsychological assessment;
- Visual system disorders (blindness, glaucoma);
- Atypical parkinsonisms;
- PD with dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) (American Psychiatric Association).
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Right prismatic adaptation, right virtual primastic adaptation
Participants will undergo either right prismatic adaptation or right virtual prism adaptation, along with cognitive and motor assessments. |
Participants will fit with prismatic goggles that deviate their visual field by 13° either leftward or rightward. They will seat in front of a white horizontal board on which three target dots (5 mm diameter) were positioned at 0, -10 and +10° from their body midline at a distance of 57 cm from their eyes. They will perform a total of 150 verbally instructed pointing movements with their right index finger towards the right (+10°) and left (-10°) targets in a pseudorandom order. Tear film will be collected from the right and left eyes. |
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实验性的：Left prismatic adaptation, left virtual prismatic adaptation
Participants will undergo either left prismatic adaptation or left virtual prism adaptation, along with cognitive and motor assessments. |
Participants will fit with prismatic goggles that deviate their visual field by 13° either leftward or rightward. They will seat in front of a white horizontal board on which three target dots (5 mm diameter) were positioned at 0, -10 and +10° from their body midline at a distance of 57 cm from their eyes. They will perform a total of 150 verbally instructed pointing movements with their right index finger towards the right (+10°) and left (-10°) targets in a pseudorandom order. Tear film will be collected from the right and left eyes. |
|
假比较器：Neutral prismatic adaptation, neutral virtual prismatic adaptation
Participants will undergo neutral prism adaptation or neutral virtual prism adaptation, along with cognitive and motor assessments. |
Participants will fit with prismatic goggles that deviate their visual field by 13° either leftward or rightward. They will seat in front of a white horizontal board on which three target dots (5 mm diameter) were positioned at 0, -10 and +10° from their body midline at a distance of 57 cm from their eyes. They will perform a total of 150 verbally instructed pointing movements with their right index finger towards the right (+10°) and left (-10°) targets in a pseudorandom order. Tear film will be collected from the right and left eyes. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improve visuospatial skills;
大体时间：2 years
|
Better performance in tests that evaluate visuospatial skills like line bisection test. The minimun value is 0 and the maximum is 3. Higher scores mean a worse outcome |
2 years
|
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Modulate alexithymia;
大体时间：2 years
|
improvement in tests evaluating alexithymia such as TAS-20. The TAS 20 has scores that have a minimum of 20 and a maximum of 100. Scores greater than or equal to 61indicate high levels of alexithymia |
2 years
|
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Investigation of brain activity;
大体时间：2 years
|
investigate the brain areas involved in the tasks with High Density Electroencephalography (EEG HD) and functional near infrared spectroscopy (fNIRS). The most active areas will be listed in a table |
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improve the quality of life with PDQ-39 questionnaire
大体时间：2 years
|
Promote rewarding experiences that improve self-esteem, the perceived sense of self-efficacy, the quality of life measured with the Parkinson's disease questionnaire (PDQ-39).The minimum score is 0 which indicates the best quality of life A maximum score is 100 which indicates the worst quality of life. |
2 years
|
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Non invasive biomarker
大体时间：Until the end of the study
|
we would like to evaluate production of the tear film and correlate their quantity with the severity of PD as it could be proposed as a new, non-invasive biomarker. |
Until the end of the study
|
合作者和调查者
调查人员
- 首席研究员：Laura Culicetto、IRCCS Centro Neurolesi Bonino Pulejo
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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