Clinical trial NCT06686563: WAVE: AudioVisual Stimulation Enhances Cognitive, Mental and Physical Health in Elderly
Official title: Audiovisual Stimulation in Elderly (Older Adults?): Effects on Cognition, Depressive Symptoms, and Dual Motor-Cognitive Tasks - a RCT
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Cognitive decline
Depressive symptoms
Audiovisual stimulation
Inflammaging
Older adults
Lead sponsor: Cooperativa de Ensino Superior, Politécnico e Universitário
Sponsor class: OTHER
Collaborators: name: Universidade do Sul de Santa Catarina
First posted: 2024-11-13
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blind randomized controlled clinical trial will be conducted with 48 elderly volunteers from a daycare center in Famalicão. After an initial cognitive screening (MoCA), assessment of depressive symptoms (GDS-15), agility and functional balance (TUG), and chronic inflammatory conditions (blood analysis), participants will be randomly assigned to a group (IG: intervention group; CG: control group). Participants in the CG will be stimulated with theta frequency (4-7 Hz), while participants in the IG will be stimulated with gamma frequency (39-42 Hz). For both groups, the frequency of the intervention will be 5 times a week, with the AVNS being used twice a week for 20 minutes (a minimum of 20 sessions - 8 to 12 weeks) and the other 3 days being spent at home with 20 minutes of audio frequency stimulation at the appropriate frequency (GC: theta, GI: gamma). After this period, all participants will be re-evaluated.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Know how to read and write

Exclusion Criteria:

-

Primary outcomes:
measure: Cognitive screening
timeFrame: From enrollment to the end of intervention
measure: Performance of the dual motor-cognitive task
timeFrame: From enrollment to the end of intervention
measure: Blood biomarkers for chronic inflammatory conditions
timeFrame: From enrollment to the end of intervention
Secondary outcomes:
measure: Depressive symptoms
timeFrame: From enrollment to the end of intervention
Other outcomes:
Locations:
city: Gandra
country: Portugal
facility: Cooperativa Ensino Superior Politécnico e Universitário
state: Paredes
Study officials:
affiliation: CESPU University
name: Anna Quialheiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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