Investigating Visuo-spatial Abilities and Psychological Effects in West Nile and Multiple Sclerosis Patients with a Focus on a Possible Rehabilitation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Measure of changes in cognitive performance after the treatment
研究概览
简要总结
The study aims to investigate visuospatial abilities and psychological outcomes in patients with multiple scleroris (MS) and patients with West Nile virus infection (vWN). Patients will undergo a specific neuropsychological and psychological evaluation. Afterwards, patients will receive 10 sessions of cognitive training integrating digital exercises and prismatic lenses. At the end of the treatment, patients will be re-evaluated to explore for potential changes in the cognitive and psychological profile.
详细描述
Over time, the literature has investigated the impairment of cognitive and psychological aspects in patients with vWN and MS, due to the fact that both conditions can affect normal cognitive functioning.
As far as VWN is concerned, most cases in humans are asymptomatic, while about 20% of infected subjects develop a disease defined as West Nile fever, characterized by symptoms such as fever, headache, muscle pain, possible skin rashes, and lymphadenopathy. Less than 1% of infected people develop a form of the virus defined as neuro-invasive, which can manifest itself through encephalitis, meningitis, and flaccid paralysis. From a cognitive point of view, following the development of the disease, the difficulties mainly reported by patients concern memory loss, the decrease in motor skills, the onset of depression, and the inability to carry out the activities of daily life as before the illness. Furthermore, deficits in attention and executive functions have been identified through the use of neuropsychological tests. The few studies present in the literature that have investigated the state of the cognitive system in patients with vWN often do not agree with the definition of a characteristic pattern. Therefore, a short pilot was carried out to evaluate cognitive deficits in patients with VWN outcomes currently hospitalized at the San Camillo IRCCS. From this pilot, it emerged that the main difficulties concern the attentional, executive, and visuospatial functions.
Even in MS, a chronic inflammatory, demyelinating, and degenerative disease of the central nervous system, cognitive deficits are often present, especially in patients with the Relapsing Remitting or Progressive form. Furthermore, more than 50% of patients experience depression. Cognitive impairment can affect specific functions or be severe and widespread, depending on the location of the brain lesions caused by the disease. In any case, the most affected cognitive functions are attention and information processing speed, short and long-term memory in its explicit subcomponent and prospective memory, executive functions, language, and visuospatial functions. However, as far as the latter are concerned, on the one hand, there are few studies that have investigated the visuospatial component in MS; on the other, these studies report inconsistent results, also due to the heterogeneity in the applied tests and in the terminology used to define these deficits. In these studies, in fact, the difference between visuospatial and visuo-perceptive deficits is not always clear, with a consequent, sometimes non-specific use of the relative tests.
Since the literature has not investigated the visuo-spatial deficit in vWN disease, further studies are needed to explore this disorder in patients with vWN infection outcomes and with MS for the role that this function plays in daily life. In fact, visuo-spatial skills allow the person to relate correctly with the surrounding environment, orienting himself and regulating his own behavior according to it. A deficit at this level compromises both personal and professional quality of life.
The present study arises from the need to investigate more fully the visuo-spatial component in patients with vWN infection outcomes and with MS and aims to evaluate the effectiveness of an innovative tool for its treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of: Multiple Scleroris OR vWN infection ascertained by laboratory analysis and received no later than twelve months prior to the date of hospitalization
- •preserved use of at least one hand
- •normal or corrected to normal vision
排除标准
- •history of psychiatric and/or concurrent neurological diseases
- •inability to provide informed consent,
- •impaired comprehension of oral instructions,
结局指标
主要结局
Measure of changes in cognitive performance after the treatment
时间窗: At baseline and after 2 weeks (post-intervention)
Cognitive performances will be assessed by a full neuropsychological battery encompassing the main cognitive domain, such as memory, attention, executive function, language, visuospatial abilities. Specific neuropsychological tests will be defined on the basis of the specific neurological population. Raw scores at each test and scale will be converted in z-scores based on each test/scale normative data. Z-scores will be averaged to calculate composite scores specific for each cognitive domain and for motor functioning. In detail, the composite scores will be the following: general cognitive functioning, attention, executive function, short-term memory, long-term memory, visuospatial abilities, language.
次要结局
- Measure of changes in psychological aspects after the treatment(At baseline and after 2 weeks (post-intervention))
