Cognitive Dysfunction Cognition
Conditions
Interventions
This is a randomized, controlled, three-arm, multicenter, double-blind clinical trial. Patients will receive audiovisual stimulation (AVA) for 20 minutes twice a week (20 sessions - 3 months), startin
Sponsors
Sociedade de Educação Superior e Cultura Brasil S.A.
Sociedade de Educação Superior e Cultura Brasil S.A.
Eligibility
Age
50 Years to 69 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; aged between 50 and 69 years; diagnosed with mild cognitive impairment (MCI); possessing a score higher than 12, without a diagnosis of dementia, and lower than 26 points on the MoCA test.
Exclusion criteria
Exclusion criteria: Individuals with epilepsy; immunocompromised individuals; those with oncological and infectious diseases; those diagnosed with bipolar disorder; those with pacemakers; and participants with hypersensitivity to light.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The cognitive status of the population is expected to be quantified using the Montreal Cognitive Assessment. Individuals with scores above 12, without a diagnosis of dementia, and below 26 points will be eligible to be included in the study sample. The assessment will be conducted before treatment and after the end of treatment (3 months of intervention). | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep quality will be assessed using the Pittsburgh Quality of Sleep Index (PSQI-BR). The overall score will range from 0 to 21, with scores above 5 indicating poor sleep quality. Participants will be evaluated before and after treatment (3 months of intervention).;Motor function will be assessed using the Timed Up and Go (TUG) test. The procedure involves timing how long it takes an individual to stand up from a standard chair, walk a distance of three meters, turn around, return to the chair, and sit down again. Execution times greater than 12.47 seconds are associated with a higher risk of falls in older adults. Participants will be evaluated before treatment and after the end of treatment (3 months of intervention).;Depression levels are expected to be assessed using the Geriatric Depression Scale (GDS-15), in its reduced 15-item version. Scores of 0 to 5 are considered "normal"; 6 to 10 points indicate "mild depression"; and 11 to 15 points are associated with "severe depression". Participants will be assessed before treatment and after the end of treatment (3 months of intervention).;It is expected to find the activity of the autonomic nervous system by analyzing heart rate variability at the beginning and end of the study;It is expected to observe the prefrontal cortex activity by analyzing cerebral blood flow at the beginning and end of the study;It is expected to observe the body composition through bioimpedance analysis at the beginning and end of the study;Differences are expected in serum concentrations of Brain-Derived Neurotrophic Factor (BDNF) at the beginning and end of the study. | — |
Countries
BR, PT
Contacts
Public ContactDaniel Martins
Universidade do Sul de Santa Catarina
Outcome results
None listed