Assessment and Rehabilitation of Visuospatial and Affective Abilities in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Improve visuospatial skills;
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •- 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).
研究组 & 干预措施
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.
干预措施: Prismatic adaptation (Other)
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.
干预措施: Schirmer test (Diagnostic Test)
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.
干预措施: Prismatic adaptation (Other)
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.
干预措施: Schirmer test (Diagnostic Test)
Neutral prismatic adaptation, neutral virtual prismatic adaptation
Participants will undergo neutral prism adaptation or neutral virtual prism adaptation, along with cognitive and motor assessments.
干预措施: Prismatic adaptation (Other)
Neutral prismatic adaptation, neutral virtual prismatic adaptation
Participants will undergo neutral prism adaptation or neutral virtual prism adaptation, along with cognitive and motor assessments.
干预措施: Schirmer test (Diagnostic Test)
结局指标
主要结局
Improve visuospatial skills;
时间窗: 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
Modulate alexithymia;
时间窗: 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
Investigation of brain activity;
时间窗: 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
次要结局
- Improve the quality of life with PDQ-39 questionnaire(2 years)
- Non invasive biomarker(Until the end of the study)
研究者
Laura Culicetto
psychologist
IRCCS Centro Neurolesi Bonino Pulejo