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临床试验/NCT04111640
NCT04111640Unknown不适用

Evaluation of the Effectiveness of a Computerized Cognitive Training in the Early Stages of Neurodegenerative Diseases

IRCCS National Neurological Institute "C. Mondino" Foundation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年3月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Change in Global cognitive functioning measured by Mini-Mental State Examination (MMSE)

研究概览

简要总结

The prevalence of neurodegenerative diseases is expected to increase over the next years, in parallel to the aging of the world population. Therefore, research efforts need to be devoted to evaluate intervention strategies that delay the onset of cognitive decline. Given the paucity of pharmacological interventions, strategies for non-pharmacological enhancement, such as cognitive training, are receiving increasing attention. Moreover, the advances in the development of Information & Communication Technologies (ICT) has recently prompted the possibility to develop computer-based solution, also called Serious Game (SG), for the training of one or more cognitive functions. This approach could help overcome the limits of traditional paper-and-pencil cognitive intervention techniques. However, the clinical, ethical, economic and research impact of the use of these computer-based solutions in these target populations is still under discussion. In order to acquire more academic and professional credibility and acceptance, researchers need to collect more data to test and evolve usability and usefulness of SG as clinical tools targeting people with dementia-related disorders.

The general aim of this research is to evaluate the effects of a computer-supported Cognitive Training (CT) compared to a paper-and-pencil CT, in the early stage of neurodegenerative diseases. Patients with Mild Cognitive Impairment (MCI) are enrolled and randomly assigned to the experimental group (CoRe software) or control group (paper-and-pencil CoRe version). All patients are evaluated before (T0) and after (T1) treatment with an exhaustive neuropsychological assessment. Furthermore, follow-up visits are scheduled 6 months (T2) and 12 months (T3) after the end of the treatment.

详细描述

Serious games (SG), are digital applications specialized for purpose other than entertaining. These technology devices could help to overcome the limits of traditional paper-and-pencil approaches. These traditional interventions, even if particular familiar to older patients, involve indeed some disadvantages, such as data management and analysis particularly complex for therapists; possible learning effects related to stimuli, boredom and reduction of the patient's compliance.

Conversely, SG uses motivational cues and provides real-time feedback; task complexity and response time demands may change frequently during and across sessions, in accordance with changes in individual performance. This allows to avoid over- or under-stimulation and to train areas of relative weakness. Computer support also saves time for therapists in the preparation of exercises and allows to record all session parameters for further statistics. Talking about disadvantages, the more critical is that elderly people might have poor information technology skills with a consequent lack of familiarity with technological devices. These difficulties derive from the fact that most of the SG used have been developed for entertainment purposes (e.g., the Nintendo Wii Fit, Wii Sports, and Big Brain Academy) and for a "typical healthy user" in mind. Some practical recommendations for the usability and usefulness of SG as clinical tools in dementia-related disorders were collected, but there is still no a general consensus about how, when and for what purpose these digital games should be developed. In fact, in the contest of neurodegenerative disease, cognitive intervention to be effective must be proportionate to the degree of cognitive deterioration and consequently it is necessary to take into account the phases of the disease, the specific disease characteristics and the specific cognitive domains affected. Some studies suggested that computerized CT is efficacious at the early phases of the disease, or where MCI is present, while it may not be beneficial at the dementia stage. Though these emerging results are encouraging, some issue about the use of this computer-based solution as clinical tools remain unresolved.

In this frame, we develop a computer-based CT (CoRe software) for the training of logical-executive and working-memory functions. We aim to assess the efficacy of this computer-supported CT compared to a paper-and-pencil CoRe version. This could be useful for two main reasons: 1) understand the comparability of the two interventions; 2) explore possible extra advantages of the CoRe software with respect to the paper-and-pencil version that could make it more suitable for the clinical routine.

CoRe is an ontology-based software tool that allows several degrees of personalization and the possibility to generate different patient-tailored exercises; for a more detailed description see previous papers.

Inpatients with idiopathic PD are recruited from the Neurorehabilitation Unit of the IRCCS Mondino Foundation. The diagnosis of mild dementia or PD-MCI is formulated on the basis of a comprehensive neuropsychological evaluation (baseline cognitive assessment - T0) according to the guidelines presented in the literature. The following standardized tests assessing different domains are used:

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
Double (Participant, Investigator)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosis of idiopathic PD according to UKPDBB criteria (Hughes, Daniel, Kilford, & Lees, 1992) and Hoehn&Yahr scale≤4 (Hoehn & Yahr, 1967);
  • presence of PD-MCI single-domain (executive) or PD-MCI multiple-domain with executive involvement (Litvan et al., 2012);
  • age between 50 and 85 years;
  • education level ≥5 years.

排除标准

  • pre-existing cognitive impairment (e.g. aphasia,neglect);
  • severe disturbances in consciousness;
  • severe sensory or motor disturbances that do not allow the patient to control the trunk or to maintain the sitting position; in particular patients with disturbing resting and/or action tremor (corresponding to score 2-4 in the specific items of Unified Parkinson's Disease Rating Scale (UPDRS III) (Fahn,1987) were excluded;
  • concomitant severe psychiatric or neurological conditions;
  • patients with Deep Brain Stimulation.

结局指标

主要结局

Change in Global cognitive functioning measured by Mini-Mental State Examination (MMSE)

时间窗: After 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. The score is between 0-30. Lower score is worse cognitive functioning.

Change in Global cognitive functioning measured by Montreal Overall Cognitive Assessment (MoCA)

时间窗: After 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program

It is a widely used screening assessment for detecting cognitive impairment. It assesses several cognitive domains: The short-term memory recall task (5 points). Visuospatial abilities a clock-drawing task (3 points) and a three-dimensional cube copy (1 point). Multiple aspects of executive functions are assessed using an alternation task adapted from the trail-making B task (1 point), a phonemic fluency task (1 point), and a two-item verbal abstraction task (2 points). Attention, concentration, and working memory are evaluated using a sustained attention task ( 1 point), a serial subtraction task (3 points), and digits forward and backward (1 point each). Language is assessed using a three-item confrontation naming task with low-familiarity animals (3 points), repetition of two syntactically complex sentences (2 points), and the aforementioned fluency task. Finally, orientation to time and place (6 points). Low score is worse outcome.

次要结局

  • Change in Memory(after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program)
  • Change in executive functions(after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program)
  • Change in Mood (assessed by Beck Depression Inventory - BDI)(after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program)
  • Change in Quality of life (assessed by Short Form-36 Health Survey - SF-36)(after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program)
  • Change in The evolution of cognitive profile (assessed by Clinical Dementia Rating Scale - CDR)(after 3 -week rehabilitative program (T1), 6 months (T2) and 1 year (T3) after the end of rehabilitation program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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