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临床试验/NCT03680170
NCT03680170Unknown不适用

The Effect of Home-based Working Memory Updating Training on Cognition and Health in Patients With Parkinson's Disease

Umeå University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Criterion task

研究概览

简要总结

The aim of the iPARK-study is to investigate the effects of a process-based cognitive training program with focus on working memory in patients with Parkinson's Disease (PD). The study is a double blinded, randomized controlled trial with a parallel group design that aim to recruit 80 persons with PD. All patients will undergo 30 sessions (6-7 weeks) of web-based cognitive training performed at home. The working memory training is a process-based training program focusing specific on updating. The placebo program is a low dose short term memory paradigm without updating. A battery of neuropsychological tests (working memory, attention, episodic memory, inhibition control, risk taking and motoric speed) and questionnaires (everyday functioning and psychological health) will be performed before training and directly after training and after 16 weeks. Patient expectation and measures of adherence (motivation and results during training) will be controlled for.

The iPARK trial is expected to provide novel and clinical useful information whether updating training is an effective training paradigm in PD. Further it will hopefully contribute to a better understanding of cognitive function in PD.

详细描述

Parkinson's Disease (PD) is after Alzheimers disease (AD) the most common neurodegenerative disease with a prevalence of 1% of the population over 60 years of age. The cardinal symptoms are motoric and are believed to be caused by depletion of dopamine in the brain with severe depletion in the striatum. In addition to the motor impairments, there are several non-motor functions also affected, where cognitive decline and dementia are among the most common problems. Some claim that up to 75% of the total PD population will eventually develop dementia. Prior to dementia, milder cognitive problems are common and already at the time of diagnosis up to 42.5% of patients with PD are affected by decline in different cognitive functions. Early cognitive deficits seen is inhibition, shifting, working memory and planning, but a cognitive profile of visuospatial decline, semantic fluency and episodic memory has been connected to Parkinson's Disease Dementia (PDD). The occurrence of Lewy-bodies and Alzheimer type brain pathology is common in PDD but dopamine depletion has also been connected to cognitive decline in healthy elderly and in PD.

Although prescription of dementia medication in PD most likely has increased during the last decade there are limited evidence of treatment effects . This particular patient group is already burdened by polypharmacy and therefore investigating non-pharmacological interventions is of crucial importance. A recent systematic review of cognitive intervention studies in PD suggests that there is evidence of clinically meaningful improvements in overall cognition and moderate to large effect sizes on measures of working memory, processing speed and executive functions. Another review on the topic suggested that the results are promising, at least in the immediate or short term for some cognitive domains, but due to inconsistencies between studies and lack of methodological salience there are still a lot of questions unanswered. Baseline factors such as cognitive functioning, Hoehn and Yahr stage, premorbid intelligence all can have contributing effects on individual differences in training gain. Therefore it is important to thoroughly investigate baseline characteristics.

In the future, studies need to include more participants, be hypothesis driven and include more detail of the cognitive profile, training intervention and outcome measures.

One approach to cognitive training that has received a lot of attention and critique is process-based cognitive training, such as training focusing on working memory (WM) and executive functions (EF). The purpose of the process based approach is to strengthen general cognitive processes important to global cognitive functioning. WM and EF play central roles in several different functions such as episodic memory, reading comprehension and problem solving to mention a few. Research has also shown that WM and EF is negatively affected both in normal and pathological aging, such as PD.

Training of executive functioning and working memory have gained some promising results in healthy adults, showing improvements in working memory and executive functioning but there is also an indication of broader generalizations of training gain. Previously the effect of process-based updating training in healthy young and older individuals has been studied. Results showed that a period of updating training increased Blood Oxygen Level Dependent (BOLD) activity in striatum related to increased cognitive performance in both groups. Also a corresponding effect of training on dopaminergic neurotransmission was detected.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

At the pre and first post test the person performing the testing is blinded to which group the participant is allocated to. The participant is blinded to which intervention he/she is participating in. At the second post-test the research assistant know which training the participant has been allocated to. Person performing the statistical analysis will be blinded to study group allocation.

入排标准

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

入选标准

  • •Diagnosis of Parkinson's Disease according to United Kingdom Parkinson's Disease Brain Bank (UKPDSBB) criteria
  • •Hoehn and Yahr stage I-III
  • •Pathological dat scan
  • •A score of 24 or over on the MMSE AND be without Dementia
  • •Stable medication over the past three months
  • •Owns and is able to use a home based computer or tablet with internet connection.

排除标准

  • •Unstable medication
  • •Ongoing cognitive training
  • •Diagnosis of PDD
  • •Drug or alcohol abuse

研究组 & 干预措施

Working memory updating training

Experimental

Training with web-based program on the internet for 30 sessions (4-5 times a week). The result of the training is registered.

Intervention Device: web-based cognitive training

干预措施: Working memory updating training (Behavioral)

Placebo training

Placebo Comparator

Low dose, short term memory training. Intervention: Training with computer based program on the internet for 30 sessions (4-5 times a week).

Intervention Device: Web-based cognitive training

干预措施: Placebo training (Behavioral)

结局指标

主要结局

Criterion task

时间窗: 16 weeks (posttest 1-posttest 2)

Maintenance of Letter memory performance four months after completed working memory training. total score:0-40 higher score indicate better performance total items:0-10 higher score indicate better performance

Criterion task

时间窗: 6-8 weeks (pretest-posttest 1)

Improvement on Letter memory after 30 sessions of working memory training. total score:0-40 higher score indicate better performance total items:0-10 higher score indicate better performance

次要结局

  • working memory total score(16 weeks (posttest 1-posttest 2))
  • Transfer task Stroop test(16 weeks (posttest 1-posttest 2))
  • Updating total score(16 weeks (posttest 1-posttest 2))
  • Transfer task episodic memory(16 weeks (posttest 1-posttest 2))
  • Transfer task digit span(16 weeks (posttest 1-posttest 2))
  • Mental and psychomotor speed total score(16 weeks (posttest 1-posttest 2))
  • Transfer task n-back(16 weeks (posttest 1-posttest 2))
  • Transfer task Perdue pegboard(16 weeks (posttest 1-posttest 2))
  • Transfer task Trail Making Test(16 weeks (posttest 1-posttest 2))
  • Transfer task digit memory running span(16 weeks (posttest 1-posttest 2))
  • Transfer task Digit symbol(16 weeks (posttest 1-posttest 2))
  • Transfer task subjective cognitive complaints(16 weeks (posttest 1-posttest 2))
  • Transfer task visuospatial-span(16 weeks (posttest 1-posttest 2))
  • Transfer task Matrices (WAIS IV)(16 weeks (posttest 1-posttest 2))
  • Executive function total score(16 weeks (posttest 1-posttest 2))
  • Transfer task n-back(6-8 weeks (pretest-posttest 1))
  • Transfer task digit memory running span(6-8 weeks (pretest-posttest 1))
  • Updating total score(6-8 weeks (pretest-posttest 1))
  • Transfer task episodic memory(6-8 weeks (pretest-posttest 1))
  • Transfer task digit span(6-8 weeks (pretest-posttest 1))
  • Transfer task visuospatial-span(6-8 weeks (pretest-posttest 1))
  • working memory total score(6-8 weeks (pretest-posttest 1))
  • Transfer task Matrices (WAIS IV)(6-8 weeks (pretest-posttest 1))
  • Transfer task Digit symbol(6-8 weeks (pretest-posttest 1))
  • Transfer task Perdue pegboard(6-8 weeks (pretest-posttest 1))
  • Mental and psychomotor speed total score(6-8 weeks (pretest-posttest 1))
  • Transfer task Stroop test(6-8 weeks (pretest-posttest 1))
  • Transfer task Trail Making Test(6-8 weeks (pretest-posttest 1))
  • Executive function total score(6-8 weeks (pretest-posttest 1))
  • Transfer task subjective cognitive complaints(6-8 weeks (pretest-posttest 1))

研究者

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

Anna Stigsdotter Neely

Professor

Umeå University

研究点 (1)

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