WAVE: AudioVisual Stimulation Enhances Cognitive, Mental and Physical Health in Elderly

Not Applicable

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT06686563
• Lead Sponsor: Maria Paço

Brief Summary

The goal of this randomized controlled trial is to 1) carry out a screening of cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults; 2) analyze the influence of AVNS on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults.

The main question it aims to answer is: "Does AVNS have influence on cognitive function, depressive symptoms, agility and functional balance and chronic inflammatory conditions in older adults ". Participants will be randomly assigned to a control group or to a intervention group, where they will use AVNS to see if influences the above mentioned outcomes, compared to the no intervention (control) group.

Detailed Description

Mild Cognitive Impairment (MCI) can be defined as a pre-dementia symptom and, when associated with aging, characterizes individuals with cognitive decline below the level of dementia. This decline, which can begin as early as 45 years of age, leads to impairments in memory, learning, language, orientation, and executive functions, which are more visible from the sixth decade of life onwards, with a risk of reduced autonomy and independence, and is seen by researchers as the first stage of a process of loss. This loss is progressive, lasting several years and resulting in MCI, characterized by objective cognitive loss, which does not yet compromise autonomy but has a conversion rate to dementia of 10% per year. Cognitive decline can be accompanied by increased depressive symptoms and decreased functional capacity and is related to inflammatory conditions, described in the literature as "inflammaging". Studies with beat stimulation have shown benefits in different important outcomes of cognitive function and depression. Thus, audiovisual neurostimulation (AVNS) is a possible non-pharmacological treatment that might have a direct influence on the brain wave patterns, altered in MCI and depression, modulating these specific wave frequencies to functional patterns similar to those found in healthy individuals. Having this, it can also influence agility and functional balance and reduce chronic inflammatory conditions.

Study Timeline

• Study First Submitted: 2024-07-17
• Status Verified: 2024-11
• Study Start: 2024-11
• Study First Submitted QC: 2024-11-11
• Last Update Submitted: 2024-11-11
• Study First Posted: 2024-11-13
• Last Update Posted: 2024-11-13
• Primary Completion: 2024-12
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Know how to read and write

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive screening	From enrollment to the end of intervention	Montreal Cognitive Assessment (MoCA)
Performance of the dual motor-cognitive task	From enrollment to the end of intervention	Timed Up and Go (TUG)
Blood biomarkers for chronic inflammatory conditions	From enrollment to the end of intervention

Secondary Outcome Measures

Name	Time	Method
Depressive symptoms	From enrollment to the end of intervention	Geriatric Depressive Scale 15 items (GDS-15)

Trial Locations

Locations (1)

Cooperativa Ensino Superior Politécnico e Universitário; 🇵🇹 Gandra, Paredes, Portugal