Immersive Virtual Reality Training for Improving Cognition in Adults With Metabolic Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

Immersive VR-Based Multimodal Intervention (Virtual-METS): This intervention consists of a 12-week, group-based program using immersive virtual reality technology (MK360) without head-mounted displays. Each 60-minute session combines mindfulness practices adapted from the Mindfulness-Based Stress Reduction (MBSR) program, cognitive training targeting attention, processing speed, memory, and executive function through realistic virtual environments (such as parks, markets, or home interiors), and chair-based physical exercises focused on balance, stretching, and muscle strengthening. The intervention is delivered in small groups of five participants, twice per week, for a total of 24 sessions, and is led by a trained neuropsychologist.

Study summary

This study aims to evaluate the effectiveness of a multimodal intervention using immersive virtual reality (Virtual-METS) to improve cognitive function in middle-aged adults with metabolic syndrome and subjective cognitive complaints. The intervention combines cognitive training and physical exercise in group sessions over 12 weeks.

Eligibility

Primary outcome measure(s)

• Differences between groups in scores of global cognition — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Global cognition is assessed with the Montreal Cognitive Assessment (MoCA) a screening tool designed to identify mild cognitive impairment (MCI) and other cognitive deficits. The MoCA takes around 10-15 minutes to complete and consists of 30 items (range=0-30). Higher scores mean a better outcome.
• Differences between groups in scores of sustained attention — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Sustained attention is measured with the Test of Word Accentuation. Scores range from 0-30, higher scores mean a better performance.
• Differences between groups in verbal memory — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Verbal memory is measured with the Auditory Verbal Learning Test (AVLT). It is a word-learning test where five presentations of a 15-word list are given, each followed by an attempted recall. This is followed by a second 15-word interference list (list B), followed by recall of list A. Delayed recall and recognition are also tested. For each trial, the score ranges from 0 to 15, with higher scores indicating better memory performance. The total learning score (sum of the five List A trials) ranges from 0 to 75. Delayed recall and recognition scores also range from 0 to 15. Higher scores indicate better verbal memory performance.
• Differences between groups in scores of auditory attention — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Auditory attention is measured with Digit Span Forward (WAIS-IV). Participants are asked to repeat numbers in the same order as read aloud by the examiner. Scores range from 2 to 8, with higher scores indicating better attention span.
• Differences between groups in scores of working memory — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Working memory is assessed using Digit Span Backward (WAIS-IV), where participants repeat number sequences in reverse order. Scores range from 2 to 8, with higher scores indicating better working memory.
• Differences between groups in scores of processing speed — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Processing speed is measured with the Digit Symbol Coding subtest from the WAIS-III. It consists of replacing symbols that lack verbal meaning with numbers based on a key. Scores range from 0 to 133, with higher scores indicating better processing speed.
• Differences between groups in scores of sustained attention and impulsivity — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Conners Continuous Performance Test - 3rd Edition (CPT-3) is task-oriented computerised assessment of attention-related problems. Participants are presented with a repetitive array of visual stimuli on a computer screen for 14 min. Participants are instructed to press the space bar every time a letter other than "X" appears and to not press the space bar when "X" appears. The rate of stimulus presentation varies according to 1, 2, and 4 s intervals throughout the task. Measures: Correct Detection (Higher rates indicate better outcome), Reaction times (Lower scores indicate better outcome), Omission errors (Lower rates indicate better outcome), and Commission errors (Lower rates indicate better outcome).
• Differences between groups in scores of visuospatial memory — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Visuospatial memory is assessed with the Brief Visuospatial Memory Test - Revised (BVMT-R). Immediate memory is evaluated through the total score of three learning trials, with scores ranging from 0 to 36. Delayed memory is assessed through free recall (score range: 0 to 12) and recognition (number of correctly identified figures, corrected for false positives). Higher scores indicate better visuospatial memory performance.
• Differences between groups in scores of logical memory — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Verbal episodic memory is assessed with Logical Memory I and II (WMS-IV), evaluating immediate and delayed recall of short stories. Scores range from 0 to 25 for each story, with a maximum total score of 50 when two stories are administered. In addition, a recognition phase is included, with scores ranging from 0 to 30. Higher scores across all components indicate better verbal episodic memory.
• Differences between groups in scores of visual scanning and processing speed — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Visual scanning and processing speed are measured with the Trail-Making Test-A version. Participants are asked to connect a series of numbered circles on a page in numerical order. Completion time is recorded in seconds, with lower scores indicating better performance.
• Differences between groups in scores of executive function and cognitive flexibility — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Executive functioning and cognitive flexibility are measured with the Trail-Making Test-B version. Participants are asked to connect a series of circles that contain both numbers and letters in alternating numerical and alphabetical order. Completion time is recorded in seconds, with lower scores indicating better performance.
• Differences between groups in scores of executive functioning — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Executive functioning is assessed with the Modified Wisconsin Card Sorting Test (M-WCST), which evaluates abstract reasoning, cognitive flexibility, and the ability to shift problem-solving strategies. Performance is scored based on the number of categories completed, total errors, and perseverative errors. Higher scores in perseverative errors (range: 0 to \>23) and total errors (range: 0 to \>31) indicate worse performance, while more categories completed reflect better executive functioning (range: 0 to 8).
• Differences between groups in scores of selective attention, inhibition, and processing speed — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Selective attention, inhibition, and processing speed are measured with the Stroop Color and Word Test. Participants are asked to name the color of a series of color patches (Stroop Color Naming), read a series of color words (Stroop Word Reading), and name the color of a series of color words where the word and color do not match (e.g., the word "red" written in blue ink), Stroop Color-Word Interference. Higher scores mean a better outcome.
• Differences between groups in scores of phonetic fluency — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Phonemic verbal fluency is assessed using the PMR test, in which participants are asked to produce as many words as possible beginning with the letters P, M, and R, one minute per letter. The total score is the sum of all correct, non-repeated words across the three trials. Higher scores indicate better phonemic fluency and executive function.
• Differences between groups in scores of semantic verbal fluency — Baseline, post-intervention (12 weeks), and 6-month follow-up.
  Semantic verbal fluency is assessed with a category fluency task in which participants are asked to name as many words as possible belonging to a specific semantic category (e.g., animals, fruits) within one minute. The total score is the number of correct, non-repeated words produced. Higher scores indicate better semantic fluency and lexical access.

Trial sites (1)

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