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临床试验/NCT07690865
NCT07690865尚未招募不适用

Investigating the Effectiveness of Personalized Optimal Gamma Auditory Frequency Stimulation Intervention on Cognitive Function Enhancement: An Intervention Study

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
changes in neurophysiological function

研究概览

简要总结

This study aims to evaluate whether personalized gamma-frequency auditory stimulation enhances cognitive function and brain synchronization. While 40 Hz auditory stimulation has been widely studied, recent evidence suggests optimal frequencies vary by individual. Using a cross-over design with 20 healthy adults, the research compares "optimal" versus "non-optimal" frequencies over one-month intervention periods. Effectiveness is measured through EEG recordings and executive function tasks. The goal is to determine if personalized sensory intervention provides a more effective, non-invasive strategy for enhancing cognitive performance.

详细描述

Previous studies have shown that 40-Hz gamma-band sensory stimulation can reduce Aβ and p-tau burden and improve memory performance in AD mouse models. However, findings from human studies remain inconsistent due to differences in intervention duration and stimulation protocols. Recent studies further suggest that the optimal frequency for inducing gamma-band neural entrainment varies across individuals. In addition, a pilot study conducted in our laboratory found that the optimal auditory stimulation frequency was not necessarily 40 Hz for all participants. Therefore, the present study aims to investigate the effects of optimal auditory frequency stimulation on cognitive performance and its relationship with electrophysiological changes measured by EEG.

The study will recruit 20 cognitively healthy adults. Participants who are willing to join the study will first undergo a screening session to determine whether they meet the inclusion and exclusion criteria and whether auditory stimulation can induce significant neural entrainment. Those who meet the eligibility criteria will proceed to the intervention stage.

This study will adopt a crossover design. All participants will receive two stages of auditory stimulation intervention. Prior to the intervention, participants will be randomly assigned in a 1:1 ratio to one of two experimental groups. One group will receive optimal auditory frequency stimulation during the first stage, while the other group will receive non-optimal auditory frequency stimulation (i.e., the frequency producing the weakest neural entrainment effect). Each group will include 10 participants. During the second intervention stage, the two groups will switch experimental conditions (optimal/non-optimal auditory frequency stimulation).

Each stage will last for one month, with stimulation lasts five days per week and one hour per day. After each intervention session, participants will complete an experimental log form to record adverse effects. A one-month washout period will be implemented between the two intervention stages.

EEG recordings will be conducted before and after each intervention stage, including resting-state EEG, optimal auditory stimulation EEG recordings, and cognitive tasks.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 to 40 years old.
  • The Cognitive Abilities Screening Instrument (CASI) score is within normal ranges adjusted for age and education.
  • Participants have no history of severe neurological or psychiatric disorders (such as stroke, epilepsy, depression, migraine, etc.) that could affect cognitive function.
  • Participants have not used drugs that may affect cognitive function (e.g., benzodiazepines, anticholinergic medications, etc.).
  • Participants with normal or corrected vision (e.g., glasses or contact lenses) to normal levels.
  • Auditory stimuli induce significant neural entrainment.
  • Self-reported normal hearing

排除标准

  • Participants enrolled in any cognitive enhancement study within the past two months.
  • Participants with a history of disease that could affect cognitive function (e.g., cancer, autoimmune diseases, etc.).
  • Individuals with tinnitus or hyperacusis

结局指标

主要结局

changes in neurophysiological function

时间窗: Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)

EEG oscillation within the gamma band obtained during resting-state and the periods of optimal and non-optimal auditory stimulation will be analyzed to evaluate and compare the neurophysiological changes.

changes in working memory performance

时间窗: Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)

Behavioral performance and electrophysiological activity will be evaluated via a working memory task.

changes in inhibitory control performance

时间窗: Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)

Behavioral performance and electrophysiological activity will be evaluated via an inhibitory control task.

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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