- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07690865
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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Chia-Hsiung Cheng, Ph.D.
- 전화번호: 3854 +886-3-211800
- 이메일: ch.cheng@mail.cgu.edu.tw
연구 장소
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Guishan
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Taoyuan, Guishan, 대만, 33302
- Chang Gung University
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연락하다:
- Chia-Hsiung Cheng, Ph.D.
- 전화번호: 3854 +886-3-211800
- 이메일: ch.cheng@mail.cgu.edu.tw
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Personalized optimal gamma auditory frequency stimulation
The patient receives 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.
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Participants will receive auditory 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.
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활성 비교기: Non-optimal gamma auditory frequency stimulation
The patient receives non-optimal gamma auditory frequency stimulation at home for one month, five days per week, and one hour per day.
The stimulation frequency is selected based on the frequency that produces the weakest neural entrainment.
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Participants will receive auditory 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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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changes in neurophysiological function
기간: Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
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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.
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Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
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changes in working memory performance
기간: Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
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Behavioral performance and electrophysiological activity will be evaluated via a working memory task.
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Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
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changes in inhibitory control performance
기간: Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
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Behavioral performance and electrophysiological activity will be evaluated via an inhibitory control task.
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Stage 1 baseline (T1), post one-month intervention of stage 1 (T2), stage 2 baseline (T3), post one-month intervention of stage 2 (T4)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 202600632A3
개별 참가자 데이터(IPD) 계획
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