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CompletedNCT05658354Updated Jul 2, 2025

Cognitive Rehabilitation in People With Metabolic Syndrome and Mild Cognitive Deficits

An interventional study of Computerized cognitive program in Metabolic Syndrome and Cognitive Deficit, sponsored by University of Ioannina. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-02.

Sponsored by University of Ioannina · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Metabolic Syndrome
  • Cognitive Deficit

Keywords

  • metabolic syndrome
  • mild cognitive deficits
  • computerized cognitive rehabilitation
03

In context

Metabolic Syndrome

1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.

This study's enrollment of 50 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

University of Ioannina is the lead sponsor of 53 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Presence of any serious neurological or psychiatric condition
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Computerized cognitive program

    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

  • No intervention
    Control group

    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.

Interventions

  • OtherComputerized cognitive program

    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.

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What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

  3. 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

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

  4. 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

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

  5. 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

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

  6. Change in scores of Flanker task

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

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

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

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

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

  8. Change in scores of Set Shifting

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

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

  9. Change in scores of N-back

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

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

Secondary outcomes

  1. 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

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

07

Study locations

1 site
  • Department of Hygiene and Epidemiology, School of Medicine, University of Ioannina
    Ioannina, 45110, Greece
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05658354
Lead sponsor
University of Ioannina
Responsible party
Myrto Koutsonida (PhD candidate, University of Ioannina) — Principal investigator
First posted
Dec 20, 2022
Start date
Dec 1, 2022
Primary completion
Mar 20, 2025
Completion
Mar 20, 2025
Last update
Jul 2, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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