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临床试验/NCT06686563
NCT06686563Enrolling By Invitation不适用

Audiovisual Stimulation in Elderly (Older Adults?): Effects on Cognition, Depressive Symptoms, and Dual Motor-Cognitive Tasks - a RCT

Maria Paço2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
48
试验地点
2
主要终点
Cognitive screening

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Know how to read and write

排除标准

  • 未提供

研究组 & 干预措施

Intervention Group

Experimental

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.

干预措施: Intervention Group: Gamma stimulation (Other)

Control Group

Active Comparator

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.

干预措施: Control Group: Theta stimulation (Other)

结局指标

主要结局

Cognitive screening

时间窗: From enrollment to the end of intervention

Montreal Cognitive Assessment (MoCA)

Performance of the dual motor-cognitive task

时间窗: From enrollment to the end of intervention

Timed Up and Go (TUG)

Blood biomarkers for chronic inflammatory conditions

时间窗: From enrollment to the end of intervention

次要结局

  • Depressive symptoms(From enrollment to the end of intervention)

研究者

发起方
Maria Paço
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maria Paço

PhD

Cooperativa de Ensino Superior, Politécnico e Universitário

研究点 (2)

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