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临床试验/NCT06399978
NCT06399978尚未招募不适用

The Feasibility and Effect of Cognitive Training on Objective and Subjective Cognitive Functioning in Patients With Mild Cognitive Impairment: A Pilot Study

Pernille Louise Kjeldsen2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月6日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
2
主要终点
Visuo-spatial memory task performance assessed with a gamified visuo-spatial memory task (Starry Night)

研究概览

简要总结

The goal of this study is to assess the feasibility and effect of digital cognitive training based on the principles of Differential Outcome Training (DOT) in patients with Mild Cognitive Impairment. In DOT training, each stimulus-response pair to be learnt is followed by a unique reinforcer, as opposed to non-DOT (NDOT) training, where the stimulus-response pairs are all followed by a random reinforcer. DOT training is believed to boost learning more than NDOT training through associations.

The main questions the study aims to answer are:

  • Whether at-home, tablet-based digital cognitive training is feasible in elderly patients with Mild Cognitive Impairment
  • Whether regularly digital cognitive DOT training has a positive effect on patients' cognitive functioning and quality of life
  • Whether any potential effects that the cognitive DOT training may have on the patients' cognitive functioning are transferable to the patients' daily life.

Participation in the study includes:

  • A pre-training session at the site with the primary project coordinator, where the patient will complete a number of self-report questionnaires about their health, cognition, and quality of life as well as a neuropsychological assessment.
  • Training with the digital cognitive DOT training program at home for 20 min. per day 3-4 times a week for 6-8 weeks.
  • A post-training session at the site with the primary project coordinator after the 6-8 weeks have passed, where the patient will complete a usability questionnaire about the training programme, some of the same self-report questionnaires about their health, cognition, and quality of life as well as some of the neuropsychological assessments.
  • A 1-month follow-up session where the patients will complete some of the same self-report questionnaires again about their cognition and quality of life plus a questionnaire aimed the transferability of any positive cognitive effects of the training.

详细描述

Alzheimer's disease (AD) is the most common form of dementia, a debilitating neurodegenerative disease with cognitive impairments, especially impairments in memory, at its core. AD is progressive, with cognitive symptoms gradually worsening as AD brain pathology builds over time. The clinical construct of Mild Cognitive Impairment (MCI) represents an intermediate stage between healthy ageing and early dementia with cognitive impairment that is worse than what is seen in healthy ageing, but not enough to interfere with daily living. Although, not all MCI cases lead to dementia, the majority of cases eventually progress.

The amnestic subtype of MCI, which is especially characterised by the presence of memory impairments, is the most likely to progress to AD dementia. In line with the evolution of brain neurodegeneration in AD, typically beginning in memory-related medial-temporal limbic areas, which specifically contribute to forming and accessing spatial contextual short-term memories, spatial memory deficits are especially common in amnestic MCI. AD patients and even amnestic MCI patients perform worse on visuospatial short-term memory tasks compared to healthy participants and individuals with other neurodegenerative disorders. Memory functions are essential for daily living, and memory impairments have been shown to be a major determinant of health outcomes and well-being in age-related disorders.

At the time an MCI diagnosis is made, the pathological burden is often so high that it is almost impossible to stop or reverse the cognitive impairment. Presently, there is no cure for AD or any other type of dementia, and available pharmacological treatments have only very limited effects on cognitive symptoms. A major research priority should therefore be to develop non-pharmacological approaches, which are cost-effective and potentially feasible for large-scale implementation, to preserve and promote cognitive function and improve quality of life early on in MCI.

Previous studies have shown beneficial effects of cognitive training in MCI and AD patients using a novel training procedure that has been proposed to active and relay on memory processes and brain structures that are less affected in MCI and AD - The Differential Outcome Training (DOT). DOT training is based on the principle that each stimulus-response association to be learned is followed by a unique reinforcer, relative to a condition where reinforcers are presented randomly (non-differential outcomes training, NDOT). DOT training has been shown to result in enhanced learning, including faster acquisition, better overall retention, and higher retention accuracy, in both animals and humans. Nonetheless, the effects of a prolonged DOT training on visuospatial short-term memory performance and possible transfer of any benefits to other memory tasks and cognitive domains as well as its impact on quality of life in patients with MCI requires further research.

This study aims to establish the feasibility and effectiveness of a recently developed digital, gamified type of cognitive training in individuals with MCI. The study aims to address this by using a recently developed gamified version of the DOT task. This gamified DOT task integrates the DOT procedure within a gardening task. Participants are introduced to a botanic garden that they have to keep up, which includes cleaning up, obtaining seeds, planting plants, and putting up decorations. They can obtain seeds, plants, and money by performing a visuospatial short-term memory DOT task, which they can then use for the garden.

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, Care Provider)

入排标准

年龄范围
65 Years 至 80 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Significant systemic disease or unstable medical or psychiatric disorder
  • Past history of stroke, brain damage, head trauma, or concussion, which significantly affects level of functioning
  • Past history of significant alcohol or drug abuse
  • Significantly impaired vision or hearing
  • Colour blindness
  • Danish as a second language
  • Participation in any other clinical studies during project participation

结局指标

主要结局

Visuo-spatial memory task performance assessed with a gamified visuo-spatial memory task (Starry Night)

时间窗: Post-training (6-8 weeks)

Participants are asked to complete the 20-min gamified visuo-spatial memory task, Starry Night. Participants are presented with complex patterns somewhere on a screen for a few seconds at a time. After a short pause, different complex patterns appear on the screen, of which one was the pattern the participant just saw. The participant needs to both choose the correct pattern and then place it on the spot on the screen where it previously appeared.

Quality of life assessed with the Quality of Life Ladder (QoL Ladder)

时间窗: Post-training (6-8 weeks)

The Quality of Life Ladder is a commonly used, simple task. Participants are asked to rate their quality of life on a scale from 1 to 8, where 1 is the worst and 8 is the best possible quality of life they could realistically have.

Usability of the digital cognitive training program assessed with a self-report questionnaire

时间窗: Post-training (6-8 weeks)

Participants are asked to fill out a self-report questionnaire made specifically for this study. The questionnaire includes 10 questions about the participants' experience with the digital cognitive training post-training, including whether the programme ran smoothly, was easy to use, was engaging, and was fun, and whether the participants would be interested in playing it or similar game again in the future.

Memory task performance assessed with a Differential Outcome Task (DOT task)

时间窗: Post-training (6-8 weeks)

Participants are asked to complete a computerised face recognition DOT task. Participants are presented with different faces and asked which ones they have seen previously. The responses are each followed by an outcome. There are two versions of the task: a DOT version where each correctly identified face is associated with a certain outcome, and a NDOT version, in which the outcomes appear randomly.

Depressive symptoms assessed with the 15-Item Geriatric Depression Scale (GDS-15)

时间窗: Post-training (6-8 weeks)

Participants are asked to fill out the 15-Item Geriatric Depression scale (GDS-15). The GDS is a very commonly used measure for depressive symptoms in elderly individuals. The participants are presented with 15 yes- or no-questions. Their responses for each question are coded as either 0 or 1, where 0 indicates that depressive symptoms are not present, while a score of 1 indicates the presence of a depressive symptom. Participants can score between 0 and 15, where a higher score indicates worse mood. A cut-off score of 5 is used, insofar that participants with a score more than five likely have depression.

Subjective cognitive functioning assessed by the 20-Item Short-Form Change in Cognition Scale (CCI-S-20)

时间窗: Post-training (6-8 weeks)

Participants are asked to fill out the 20-Item Short-Form Change in Cognition Scale (CCI-S-20). This version of the questionnaire contains 20 questions about memory functions in daily life. Participants indicate on a 5-point rating scale if they think their own memory functions are the same as they have always been or if they have become worse, and if so, to which degree. Participants' ratings can be between 0 ('no change in that memory function') to 4 ('severe change in that memory function'). A higher score indicates worse cognition.

次要结局

  • Depressive symptoms assessed with the GDS-15(1-month follow-up)
  • Longterm visuo-spatial memory performance assessed with Starry Night(1-month follow-up)
  • Quality of life assessed with the QoL Ladder(1-month follow-up)

研究者

发起方
Pernille Louise Kjeldsen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pernille Louise Kjeldsen

Project coordinator

Aalborg University Hospital

研究点 (2)

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