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临床试验/NCT06942728
NCT06942728尚未招募不适用

Personalized Medicine in the Elderly With Vision Impairment and Mild Cognitive Impairment: Effects of Sensorineural Telerahabilitation

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
24
试验地点
1
主要终点
The effects of neurosensory telerehabilitation in elderly subjects with MCI

研究概览

简要总结

Globally, approximately 55 million people suffer from dementia, and 60-70% of cases are due to Alzheimer's disease (AD). Increasing scientific evidence highlights that the pathological changes underlying AD and other forms of dementia begin long before the onset of symptoms. Mild cognitive impairment (MCI) is a clinical condition that in people over 65 shows a prevalence ranging from 3% to 22%. The characteristics of MCI are the presence of a subjective memory disorder and a reduced ability to learn new information with normal general cognitive functioning, normal ability to perform daily activities and the absence of other conditions, such as depression, that could justify the memory disorder. Currently, the diagnosis of MCI is based exclusively on clinical evaluation, including neuropsychological tests.

Currently, there are no therapies available to prevent and/or treat dementia and the options for intervention are represented by treatments such as physical exercise and cognitive treatment. These practices refer to the concept of cognitive reserve. Computerized cognitive training (CCT) is characterized by being a personalized intervention, allows multi-domain training and increases the cognitive processes of patients with MCI. The National Low Vision Center has been using a software called nLIFE EyeFitness for several years, certified as a Class I Medical device. It allows you to carry out individualized rehabilitation exercises at home, using your own PC or tablet, with monitoring by the Center's operators. The exercises currently present stimulate attention, short-term visual memory, reaction time, executive function, working memory and, therefore, also appear suitable for stimulating subjects with MCI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients aged ≥ 60 years with a diagnosis of aMCI
  • •Signing of informed consent

排除标准

  • •Age <60 years
  • •History of dementia
  • •Diabetes mellitus
  • •Uncontrolled hypertension
  • •Diagnosis of major depression
  • •Age-related macular degeneration
  • •Media opacity and vitreoretinal pathologies that may preclude a correct evaluation
  • •• Failure to obtain informed consent

研究组 & 干预措施

Sperimental

Experimental

All patients will undergo:

  • Standardized battery of tests for the diagnosis of cognitive decline corresponding to the BDM (Battery for Mental Deterioration
  • Global assessment measure of cognitive status (Minimal Mental State Examination - MMSE)
  • Complete eye examination
  • Tonometry
  • Visual acuity for distance (ETDRS) and near (MNRead)
  • Reading speed (IrestTEST)
  • Microperimetry
  • Psychological evaluation
  • Patients with visual impairment randomized to receive neurovisual rehabilitation treatment will carry out neurosensory rehabilitation remotely.

干预措施: nLIFE EyeFitness (Device)

Control

No Intervention

All patients will undergo:

  • Standardized battery of tests for the diagnosis of cognitive decline corresponding to the BDM (Battery for Mental Deterioration
  • Global assessment measure of cognitive status (Minimal Mental State Examination - MMSE)
  • Complete eye examination
  • Tonometry
  • Visual acuity for distance (ETDRS) and near (MNRead)
  • Reading speed (IrestTEST)
  • Microperimetry
  • Psychological evaluation

结局指标

主要结局

The effects of neurosensory telerehabilitation in elderly subjects with MCI

时间窗: 8 months

Evaluate the effects of neurosensory telerehabilitation in terms of reduction of cognitive deterioration by evaluating the scores of neuropsychological questionnaires in use in clinical practice after using the remote neurovisual rehabilitation platform in use at the Polo Nazionale di Ipovisione

次要结局

  • Evaluation the effects of neurosensory telerehabilitation on visual tests score(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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