A Computer-based Cognitive Stimulation in Mild Cognitive Impairment With White Matter Hyperintensities

Study Overview
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Brief Summary
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This is a non-pharmacological study evaluating the impact of a computerized cognitive stimulation program on verbal learning and on the progression white matter hyperintensities in elderly with mild cognitive impairment.

Detailed Description
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White matter hyperintensities (WMH) can appear in Mild Cognitive Impairment (MCI) and have been associated to executive, attention and processing speed deficits. Some findings indicate that the presence of WMH may contribute to Alzheimer's disease (AD) in addition to ß-amyloid, suggesting a greater vulnerability of MCI. One important challenge is to prevent or slowing down the progression of WMH. Few studies investigated the effects of computerized cognitive interventions in MCI with WMH, which deserve special attention. This study aim to investigate the effects of an intensive computer-based cognitive stimulation (CCS) program on the verbal learning in episodic memory in MCI with WMH and to explore the effects on the progression of WMH at 1-year interval.

Official Title
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Effects of a Computer-based Cognitive Stimulation on the Verbal Learning and the Progression of White Matter Hyperintensities in Mild Cognitive Impairment: A Protocol for a Randomized Controlled Trial.

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Computerized Cognitive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Mild Cognitive Impairment With and without with matter hyperintensities MRI data available or accept to perform one No engagement in other cognitive intervention program Exclusion Criteria: Psychiatric and neurological disorders History of alcohol or other substance consumption Sensory and or motor deficit that could interfere with the use of computer tool Refusal MRI.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Comparison between experimental group and control group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: computerized Cognitive training<br>Experimental group will receive 1 year of a computer-based cognitive stimulation program. | Behavioral: Computerized Cognitive training<br>* Experimental group will receive 1 year of a computer-based cognitive stimulation program, first 6 months, 60-minutes twice a week and next 6 months once a week training in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.<br>|
| No Intervention: MCI control group<br>The control group will receive a usual standard care without engagement in intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Rey Auditory Verbal Learning test | Assessment of verbal learning in episodic memory | Baseline assessment in 3-weeks period before intervention, change from baseline at 6-months immediately after the end intervention, and after 3-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on Fazekas scale | Assessment of white matter hyperintentisites severity on MRI | Baseline assessment of WMH severity and evolution at 12 months immediately after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild Cognitive Impairment, white matter hyperintensities, computerized cognitive training, brain plasticity