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Completed

NCT Number: NCT05658354

Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

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.

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Key information

Conditions

Metabolic Syndrome Cognition Disorders Cognitive Deficit Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina

Ioannina, 45110, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized cognitive program

Other

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.

Primary outcomes

  1. Change in scores of the Montreal Cognitive Assessment (MoCA) test

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    MoCA is a screening test for mild cognitive dysfunction; range 0-30, higher scores represent better cognitive function

  2. Change in scores of Complex Figure tests

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    Complex Figures assess visuo-constructional ability and visual memory; range 0-36, higher scores represent better cognitive function

  3. Change in scores of Hopkins Verbal Learning Test-Revised (HVLT-R)

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    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

  4. Change in scores of Digit Span test

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    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

  5. Change in scores of semantic Verbal Fluency test

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    Verbal Fluency assesses executive function that also relies on language component; higher scores represent better cognitive function

  6. Change in scores of Flanker task

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    Flanker task assesses executive function and inhibition; range 0-48, higher scores represent better cognitive function

  7. Change in scores of Continuous Performance Test (CPT)

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    CPT assesses executive function and inhibition; range 0-100, higher scores represent better cognitive function

  8. Change in scores of Set Shifting

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    Set Shifting assesses executive function and set-shifting; range 0-104, higher scores represent better cognitive function

  9. Change in scores of N-back

    Time frame: baseline, post-intervention (3 months), follow-up (1 year from baseline)

    N-back assesses working memory; range 0-30, higher scores represent better cognitive function

Secondary outcomes

  1. Change in scores of Everyday Cognition-II (Ecog-II)

    Time frame: baseline, follow-up (1 year from baseline)

    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

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2022
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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