- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chia-Hsiung Cheng, Ph.D.
- Número de teléfono: 3854 +886-3-211800
- Correo electrónico: ch.cheng@mail.cgu.edu.tw
Ubicaciones de estudio
-
-
Guishan
-
Taoyuan, Guishan, Taiwán, 33302
- Chang Gung University
-
Contacto:
- Chia-Hsiung Cheng, Ph.D.
- Número de teléfono: 3854 +886-3-211800
- Correo electrónico: ch.cheng@mail.cgu.edu.tw
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Comparador activo: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
changes in neurophysiological function
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202600632A3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .