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临床试验/NCT02592187
NCT02592187Unknown不适用

A Cognitive Training Tool Based on Life-logging in Mild Cognitive Impairment (ReMemory-MCI)

Consorci Sanitari de Terrassa0 个研究点目标入组 30 人开始时间: 2015年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Change in attention after receiving treatment

研究概览

简要总结

Background: Mild Cognitive Impairment (MCI) is a risk factor for dementia and represents a critical window of opportunity to intervene and alter the trajectory of both cognitive and functional decline. Emerging life-logging technologies has shown a tremendous potential to increase autobiographical memory.

Objective: The main goal of the present study is to develop a Cognitive Training program (CT) for MCI based on life-logging captured by a Wearable Camera (WeC) recording specific autobiographical episodes for stimulating posteriorly episodic memory. The challenge is to create an application to manage this large collection of images, which can be easily retrieved as events by users in a therapeutic context as a multimodal cognitive stimulation. The investigators will conduct a quasi-experimental design with non-equivalent control group, evaluating the effectiveness of the life-logging re-experiencing program immediately and 3-month follow-up period.

Methodology: The design is a pretest, posttest and follow-up design, where 30 adults with MCI were sequentially allocated to one of two conditions: intervention or control group. All subjects wore a lifelogging WeC during two weeks, and subsequently they were generated several videos with the most relevant information of each event. Subjects in the Intervention Group will attend 1-hour individual training sessions 2 times per week for 14 8 weeks. Main outcomes measures will be cognitive, functional, emotional and quality of life measures, as well as biochemical measures (BDNF).

Expected results: The investigators expect the outcomes to provide preliminary evidence that autobiographical experimentation CT programs can positively impact cognitive functioning and may represent an effective strategy to improve memory and functionality in those who begun to experience cognitive decline.

研究设计

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

入排标准

年龄范围
65 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65-90 years of age
  • Meet definition criteria for MCI (Petersen, 2004)
  • Be receiving CT at least three month in Day Hospital during three months or more; c) having memory complaint, usually verified by an informant
  • Having memory complaint, usually verified by an informant
  • Memory performance below the mean score for the corresponding age and education group
  • Having normal general cognitive functioning as determined by a Mini-Mental State Examination (MMSE) score > o = 24
  • Having a reliable caregiver who can supervise the patient's daily activities
  • Having Global clinical dementia rating scale score of 0.5
  • Granted written informed consent accepting to participate in the study

排除标准

  • Neurological, psychiatric or unstable medical disorders
  • Intellectual deficiency (Premorbid Intellectual Quotient (IQ) -Vocabulary- less 85)
  • Relevant hearing, vision, motor or language deficits
  • Less than 4 years of education e) acquisition of Catalonian or Spanish languages after 15 years old

结局指标

主要结局

Change in attention after receiving treatment

时间窗: after 16 sessions treatment and 3 months

Attention was measured using the Identification Task from the computerized neurocognitive battery Cogstate and the Forward Digit Span from the Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV)

Change in memory after receiving treatment

时间窗: after 16 sessions treatment and 3 months

Memory was measured using the Logical Memory Test from the Wechsler Memory Scale, IV version (WMS-IV, Spanish version); the International Shopping List Task and the One Card Learning Task from the computerized neurocognitive battery Cogstate.

Change in executive function, set-shifting after receiving treatment

时间窗: after 16 sessions treatment and 3 months

Set-shifting was measured using the Colors Trails Test

Change in executive function, inhibition after receiving treatment

时间窗: after 16 sessions treatment and 3 months

Inhibition was measured using the Five Digit Test

Change in working memory after receiving treatment

时间窗: after 16 sessions treatment and 3 months

orking memory was measured using the One Back Task from the computerized neurocognitive battery Cogstate and the Backward Digit Span from the Wechsler Adult Intelligence Scale, fourth edition (WAIS-IV).

Change in executive function,verbal fluency

时间窗: after 16 sessions treatment and 3 months

erbal Fluency was measured using the Controlled Oral Word Association Test, spanish adaptation, and semantic fluency test using the category Animals

Change in processing speed after receiving treatment

时间窗: after 16 sessions treatment and 3 months

Processing speed was measured using the Detection Task from the computerized neurocognitive battery Cogstate battery

次要结局

  • Change in functional capacity after receiving treatment(after 16 sessions treatment and 3 months)
  • Change in subjective memory complaints after receiving treatment(after 16 sessions treatment and 3 months)
  • Change in quality of life(after 16 sessions treatment and 3 months)
  • Change in Caregiver Burden(after 16 sessions treatment and 3 months)
  • Change in Neuropsychiatric symptoms(after 16 sessions treatment and 3 months)
  • Change in depression and anxiety after receiving treatment(after 16 sessions treatment and 3 months)
  • Change in patient's self-esteem(after 16 sessions treatment and 3 months)
  • Change in patient and caregiver's perception of social support(after 16 sessions treatment and 3 months)
  • Change in neuroplasticiy(after 16 sessions treatment and 3 months)

研究者

发起方
Consorci Sanitari de Terrassa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maite Garolera

Doctor

Consorci Sanitari de Terrassa

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