Investigating the Effectiveness of Personalized Optimal Gamma Auditory Frequency Stimulation Intervention on Cognitive Function Enhancement
Investigating the Effectiveness of Personalized Optimal Gamma Auditory Frequency Stimulation Intervention on Cognitive Function Enhancement: An Intervention Study
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Chia-Hsiung Cheng, Ph.D.
- 電話番号：3854 +886-3-211800
- メール：ch.cheng@mail.cgu.edu.tw
研究場所
-
-
Guishan
-
Taoyuan、Guishan、台湾、33302
- Chang Gung University
-
コンタクト：
- Chia-Hsiung Cheng, Ph.D.
- 電話番号：3854 +886-3-211800
- メール：ch.cheng@mail.cgu.edu.tw
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Personalized optimal gamma auditory frequency stimulation
The patient receives personalized optimal gamma auditory frequency stimulation at home for 1 month, 5 days per week, and 1 hour per day.
The stimulation frequency is selected based on the frequency that produces the strongest neural entrainment.
|
Participants will receive personalized optimal gamma auditory frequency stimulation using our app downloaded in the mobile device to play the sound for 1 hour per day, 5 days a week, over 1 month.
|
|
アクティブコンパレータ：Non-optimal gamma auditory frequency stimulation
The patient receives non-optimal gamma auditory frequency stimulation at home for 1 month, 5 days per week, and 1 hour per day.
The stimulation frequency is selected based on the frequency that produces the weakest neural entrainment.
|
Participants will receive non-optimal gamma auditory frequency stimulation using our app downloaded in the mobile device to play the sound for 1 hour per day, 5 days a week, over 1 month.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
changes in neurophysiological function
時間枠：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.
|
Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
|
|
changes in working memory performance
時間枠：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.
|
Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
|
|
changes in inhibitory control performance
時間枠：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.
|
Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。