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Effects of brain stimulation and video games on cognitive and motor function in older adults with mild cognitive impairment

Acceptability, safety and efficacy of non-invasive brain stimulation on cognitive and motor functioning in older adult patients with mild neurocognitive impairment: a randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8spzvbj
Enrollment
Unknown
Registered
2025-08-14
Start date
2025-05-12
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction

Interventions

This is a two-arm, double-blind, randomized controlled clinical study. Participants will be randomized to either the treatment alone group (TAG) or the combined treatment group (CTG) after completion
L01.224.160.875
F04.754.137.506.662
E02.331.750

Sponsors

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Lead Sponsor
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Collaborator

Eligibility

Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: Present with mild impairment cognitive; both sexes (female and male); absence of dementia based on a score on the Clinical Dementia Rating scale equal or less 0,5 according to Hughes et al 1982; age between 50 and 75 years; signs of cognitive decline according to the Montreal Cognitive Assessment cutoff points, adjusted for age and education by Apolinario et al 2018; no or minimal functional impairment due to cognition according to the score on the Activities of Daily Living Questionnaire equal or less 0,33 according Medeiros and Guerra 2009; no unstable disease that prevents planned exercise, as well as absence of known organic or psychiatric condition that compromises cognition; normal or corrected visual and auditory acuity; ability to walk independently; report a minimum schooling age of four years so that there is no impairment in performance in cognitive assessment instruments due to the influence of educational level according Apolinario et al 2018 and Avila et al 2009; have not previous experience with the Nintendo Switch video game; have not undergone physiotherapy treatment in the last 2 months before the start of the study; have no metal implants in the head

Exclusion criteria

Exclusion criteria: Participants will not be included in the study if they require high-level home care; have neurological disorders; have bone deformities that make it difficult to maintain a bipedal posture; have unstable cardiovascular diseases or other uncontrolled chronic conditions that interfere with the safety and conduct of training; have a history of severe alcohol and drug abuse

Design outcomes

Primary

MeasureTime frame
Timed Up and Go Test (TUG) in single (ST) and dual task (DT). To perform the test in single task, the participant will be asked to stand up from a standardized chair (seat height of 43 cm), walk three meters forward at their usual pace, turn 180 degrees, walk back to the chair and sit down. Performance will be assessed in seconds and the timer will start from the moment the evaluator says “GO” until the participant sits down again with their back supported on the back of the chair. Participants will be instructed to walk at a comfortable and safe pace, wearing their usual shoes, without any physical assistance. To perform the test in DT, we will maintain the method described in the Mini-BESTest. In this way, participants will perform the test in ST and simultaneously count backwards from a number between 10 and 100, determined by the examiner, in 3s. The DT condition will record the time in seconds required to perform the task and the number of correct counts recorded by the examiner during the test. The dual task cost (DTC) will be calculated as the ratio of the increase in task performance time from single-task to dual-task conditions relative to the single-task condition. The cutoff score will be 10s, with higher values ??related to an increased risk of falls.

Secondary

MeasureTime frame
Global cognitive function through the repeatable battery for assessing neuropsychological status;Visual attention, processing speed and cognitive flexibility through trail making test;Selective attention and executive functions with the Stroop test;Mood and anxiety by the Hospital Anxiety and Depression Scale;Lower limb muscle strength by quadriceps femoris muscle dynamometry;Muscle strength and transfer ability by the Five times Sit-To-Stand test;Heart rate and energy expenditure by a heart monitor;Pain level by Visual Analogue Pain Scale;Level of pain interference by the Brief Pain Inventory;Postural control and risk of falls using the Mini-Balance Evaluation Scale Test;Limit of stability and area of ??the center of pressure by posturography;Participants' performance in activities of daily living using the activities of daily living questionnaire;Motor learning in game performance;Protocol adherence and security

Countries

Brazil

Contacts

Public ContactJosé Pompeu

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

j.e.pompeu@usp.br+55(11)3091-7453

Outcome results

None listed

Source: REBEC (via WHO ICTRP)