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

Maria Paço

Status: Invitation-only

Conditions: Mild Cognitive Impairment

Treatments: Other: Intervention Group: Gamma stimulation; Other: Control Group: Theta stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06686563

WAVE_56/CE-IPSN/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Know how to read and write

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Participants in the IG will be stimulated with gamma frequency (39-42 Hz). 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. The participants will be assessed (regarding the outcomes previously described) at the baseline and reassessed after 3 months.

Treatment:

Other: Intervention Group: Gamma stimulation

Control Group

Active Comparator group

Description:

Participants in the CG will be stimulated with theta frequency (4-7 Hz). 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. The participants will be assessed (regarding the outcomes previously described) at the baseline and reassessed after 3 months.

Treatment:

Other: Control Group: Theta stimulation