跳至主要内容
临床试验/NCT06281314
NCT06281314已完成不适用

VESPA 2.0 - Virtual Environment for a Superior Neuropsychiatry Second Generation

IRCCS Centro Neurolesi "Bonino-Pulejo"2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3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
已完成
入组人数
60
试验地点
2
主要终点
Montreal cognitive assessment (MoCA)

研究概览

简要总结

VESPA 2.0 is based on an integrative and ecological approach used for the treatment of cognitive dysfunction in patients with MCI or other neurodegenerative disorders.

详细描述

The goal of this study is to verify the effectiveness of the intensive-individual cognitive participation intervention (SCI-i) on the general cognitive functioning and specific cognitive functions of patients with mild or moderate cognitive decline affected by Alzheimer's dementia, Parkinson's and Multiple Sclerosis.

Participants will be subjected to cognitive training (tasks on attention, memory, language, executive functions, and visual-spatial functions) through software. They will take place using virtual cameras and virtual reality (VR) viewers. All subjects will undergo follow-up evaluation.

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
None

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with Alzheimer Disease, Multiple Sclerosis, Parkinson Disease
  • Severity of mild to moderate cognitive impairment
  • Sign informed consent

排除标准

  • Important comorbidities with psychiatric syndromes
  • Failure to sign the informed consent
  • Atypical parkinsonisms
  • Clinical conditions that involve vision-related problems.

研究组 & 干预措施

Parkinson'disease group

Experimental

Rehabilitation takes place with individual one-hour sessions per day. The stimulation intervention is organized on 4 different themes (chosen from orientation, memory, praxis, language, executive functions, attention, problem-solving, and functional activities) for 15' each.

干预措施: Vespa software (Device)

Multiple Sclerosis group

Experimental

Rehabilitation takes place with individual one-hour sessions per day. The stimulation intervention is organized on 4 different themes (chosen from orientation, memory, praxis, language, executive functions, attention, problem-solving, and functional activities) for 15' each.

干预措施: Vespa software (Device)

Alzheimer group

Experimental

Rehabilitation takes place with individual one-hour sessions per day. The stimulation intervention is organized on 4 different themes (chosen from orientation, memory, praxis, language, executive functions, attention, problem-solving, and functional activities) for 15' each.

干预措施: Vespa software (Device)

结局指标

主要结局

Montreal cognitive assessment (MoCA)

时间窗: up to 6 weeks

MoCA (Montreal Cognitive Assessment or The MoCA Test) was validated as a highly sensitive tool for early detection of mild cognitive impairment (MCI) It quickly and accurately assesses: Short term memory; Visuospatial abilities; Executive functions; Attention, concentration, and working memory; Language; Orientation to time and place Results : 26-30 points: No cognitive impairment 18-25 points: Mild cognitive impairment. 10-17 points: Moderate cognitive impairment. Fewer than 10 points: Severe cognitive impairment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Corallo

Principal Investigator

IRCCS Centro Neurolesi "Bonino-Pulejo"

研究点 (2)

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