Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

Study Overview
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Brief Summary
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The goal of this clinical trial is to investigate the possibility of rehabilitation of mild cognitive deficits in people with metabolic syndrome. We aim to implement a cognitive training program on patients with metabolic syndrome and cognitive deficits, and examine its effectiveness both post-intervention (3 months) and after 12 months. Researchers will compare two groups, the experimental group that will receive the computerized cognitive training and the control group that will receive no training.

Official Title
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Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

Conditions
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Metabolic Syndrome, Cognitive Deficit

Intervention / Treatment
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* Other: Computerized cognitive program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Presence of metabolic syndrome according to the criteria of IDF (2005) or revised NCEP-ATP III (2005) Presence of mild cognitive deficit (-1.5 SD below age and education-adjusted normative mean) in previously administered neuropsychological tests of Trail Making test (Part A & B), Verbal Fluency test (animals and letter x), Logical Memory test (immediate and delayed recall) Written informed consent to participate Exclusion Criteria: Presence of any serious neurological or psychiatric condition

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized cognitive program<br>25 participants with metabolic syndrome and mild cognitive deficits; receive health advice using the World Health Organization's guidelines for Risk Reduction of Cognitive Decline and Dementia, and perform the computerized cognitive training program (BrainHQ) for 45 minutes per session, twice per week, over the 3-month intervention period. | Other: Computerized cognitive program<br>* BrainHQ was developed by Posit Science and includes computer-based brain-training exercises organized into six categories: Attention, Brain Speed, Memory, People Skills, Intelligence, and Navigation. Participants were instructed to perform a total of 24 sessions of computerized cognitive training at home, consisting of 45 minutes of training, twice per week, over a 3-month period.<br>|
| No Intervention: Control group<br>25 participants with metabolic syndrome and mild cognitive deficits; receive health advice using the World Health Organization's guidelines for Risk Reduction of Cognitive Decline and Dementia. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores of the Montreal Cognitive Assessment (MoCA) test | MoCA is a screening test for mild cognitive dysfunction; range 0-30, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 
| Change in scores of Complex Figure tests | Complex Figures assess visuo-constructional ability and visual memory; range 0-36, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 
| Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R) | HVLT-R assesses verbal memory using a list of words; range 0-36 (immediate recall) and range 0-12 (delayed recall), higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 
| Change in scores of Digit Span test | Digit Span assesses working memory; range 0-14 (performance) and range 2-9 (span) for forward and backward condition, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 
| Change in scores of semantic Verbal Fluency test | Verbal Fluency assesses executive function that also relies on language component; higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 
| Change in scores of Flanker task | Flanker task assesses executive function and inhibition; range 0-48, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 
| Change in scores of Continuous Performance Test (CPT) | CPT assesses executive function and inhibition; range 0-100, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 
| Change in scores of Set Shifting | Set Shifting assesses executive function and set-shifting; range 0-104, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 
| Change in scores of N-back | N-back assesses working memory; range 0-30, higher scores represent better cognitive function | baseline, post-intervention (3 months), follow-up (1 year from baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores of Everyday Cognition-II (Ecog-II) | Ecog-II is a measure of everyday functioning that includes 41 items to assess memory, language, visual, spatial and perceptual abilities, planning, organization, and divided attention; higher scores represent worse everyday functioning | baseline, follow-up (1 year from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, mild cognitive deficits, computerized cognitive rehabilitation