Combined Regulatory Effects of 40 Hz eTNS and Multisensory Stimulation on Brain Networks
A Study on the Enhancing Effects of 40 Hz Combined Trigeminal-Sensory Stimulation on Working Memory
The purpose of this study is to investigate the independent and interactive effects of 40Hz auditory, visual, and external trigeminal nerve stimulation (eTNS) on brain state dynamics and functional connectivity. While 40Hz visual and auditory sensory stimulation have been explored for potential cognitive and therapeutic benefits, the underlying mechanisms on large-scale brain networks and the potential effects of combining multiple modalities remain unclear.
This study aims to determine whether multimodal co-stimulation genuinely compounds network-level effects or if targeted dual-pairings are more efficient for brain network reorganization. In this within-subject study, 23 participants will receive all eight possible combinations of 40Hz auditory, visual, and eTNS (targeting the maxillary branch) in a randomized order. Each stimulation condition will last for 5 minutes, separated by 1-minute inter-stimulus intervals. Continuous electroencephalography (EEG) will be recorded throughout the procedures to evaluate brain responses. The collected EEG data will be analyzed using microstate analysis, functional connectivity analysis, and graph-theoretic network analysis. Ultimately, the study seeks to understand how these non-invasive stimulation techniques, independently and together, drive large-scale network reorganization and optimize the balance between local specialization and global integration in the brain.
Обзор исследования
Статус
Условия
Подробное описание
Physical neuromodulation at 40 Hz has emerged as a promising therapeutic approach, with visual and auditory stimulation demonstrating the capacity to entrain gamma oscillations and confer cognitive benefits. Analogous effects have also been observed with electrical approaches, including external trigeminal nerve stimulation (eTNS). While the prevailing assumption in the field suggests that combining multiple sensory modalities will more comprehensively recruit distributed brain circuitry and yield greater therapeutic effects, the mechanistic foundations of this additive hypothesis remain contested. Furthermore, recent evidence indicates that network-level reorganization, rather than localized gamma entrainment, may represent a more causally relevant substrate for these cognitive improvements.
This study is designed to systematically characterize the independent and interactive effects of 40Hz auditory, visual, and eTNS stimulation on brain state dynamics, functional connectivity, and graph-theoretic network properties. The trial employs a fully crossed 2×2×2 within-subject design. A total of 23 participants will undergo all eight possible combinations of 40Hz stimulation modalities: sham (no stimulation), auditory only, visual only, eTNS only, auditory + visual, auditory + eTNS, visual + eTNS, and the three-way combination of auditory + visual + eTNS.
During the experimental session, the eTNS will specifically target the maxillary branch of the trigeminal nerve. The eight stimulation conditions will be administered in a randomized order for each participant. Each stimulation block will last for 5 minutes, separated by 1-minute inter-stimulus intervals to prevent carry-over effects.
Continuous electroencephalography (EEG) will be recorded throughout the session using a 32-channel eego™ mylab system (ANT Neuro, Netherlands) to capture real-time cortical responses. Following data acquisition, standard preprocessing pipelines will be applied, including notch filtering, 0.5-45Hz bandpass filtering, average re-referencing, ICA-based artifact rejection, and bad channel interpolation.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Xue-Juan Yang, Phd
- Номер телефона: 86-029-81891070
- Электронная почта: xjyang@xidian.edu.cn
Учебное резервное копирование контактов
- Имя: Xue-Juan Yang
- Номер телефона: 15691826100
- Электронная почта: xjyang@xidian.edu.cn
Места учебы
-
-
Shaanxi
-
Xi'an, Shaanxi, Китай, 71000
- Рекрутинг
- Xidian University
-
Контакт:
- Xue-Juan Yang
- Номер телефона: +8615691826100
- Электронная почта: xjyang@xidian.edu.cn
-
Контакт:
- Электронная почта: xjyang@xidian.edu.cn
-
Главный следователь:
- Chen cheng', MD
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Healthy adults aged ≥18 years old.
- Normal or corrected-to-normal vision and hearing (essential for 40Hz visual and auditory stimulation).
- Right-handedness.
- Willing to participate in the study and capable of providing written informed consent.
Exclusion Criteria:
- Personal or family history of epilepsy or seizures (crucial safety criteria for 40Hz flicker and electrical stimulation).
- History of any neurological or psychiatric disorders.
- Presence of metallic implants in the head, cardiac pacemakers, or other implanted electronic medical devices.
- Skin lesions, infections, or hypersensitivity at the eTNS stimulation site (maxillary branch of the trigeminal nerve).
- Current use of psychoactive medications or substances that may significantly alter EEG signals or brain state dynamics.
- Pregnant or lactating individuals.
- Poor sleep quality or irregular sleep-wake cycles prior to the experiment.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Experimental Crossover Group
All participants are enrolled in this single crossover arm.
Each participant will receive all eight combinations of 40Hz stimulation (auditory, visual, and external trigeminal nerve stimulation [eTNS] targeting the maxillary branch) in a randomized order, including a sham condition.
Each stimulation condition lasts for 5 minutes, separated by 1-minute inter-stimulus intervals.
|
Electrical stimulation targeting the maxillary branch of the trigeminal nerve at a frequency of 40 Hz
Auditory sensory stimulation delivered at 40 Hz for 5-minute durations
Visual sensory stimulation delivered at a frequency of 40 Hz for 5-minute durations
Inactive control stimulation designed to mimic the sensory experience of the active modalities without delivering actual 40 Hz therapeutic stimulation
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Временное ограничение |
|---|---|
|
Whole-Brain Functional Connectivity (Phase-Locking Value)
Временное ограничение: Day1 (during the single experimental session)
|
Day1 (during the single experimental session)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
EEG Microstate Dynamics (Mean Duration and Segment Density)
Временное ограничение: Up to 1 hour (during the single experimental session)
|
Brain state dynamics evaluated via microstate analysis of global field power (GFP) peaks.
Primary metrics extracted include the mean duration and segment density (occurrence rate per minute) of identified microstate classes to assess modality-specific regulation.
|
Up to 1 hour (during the single experimental session)
|
|
EEG Phase-Locking Value (PLV)-Derived Global Efficiency
Временное ограничение: Day1 (during the single experimental session)
|
Continuous electroencephalography (EEG) data will be recorded.
The specific parameter extracted from the EEG is the Phase-Locking Value (PLV) across theta (4-7Hz), alpha (8-12Hz), beta (13-30Hz), and gamma (31-45Hz) frequency bands.
These PLV functional connectivity matrices will be used to construct weighted brain networks across a sparsity threshold range of 0.1 to 0.5.
Global efficiency, a graph-theoretic metric representing network-wide communication integration, will then be calculated and reported based on these PLV networks.
|
Day1 (during the single experimental session)
|
|
EEG Phase-Locking Value (PLV)-Derived Small-World Propensity
Временное ограничение: Day 1 (during the single experimental session)
|
Continuous electroencephalography (EEG) data will be recorded.
The specific parameter extracted from the EEG is the Phase-Locking Value (PLV) across theta (4-7Hz), alpha (8-12Hz), beta (13-30Hz), and gamma (31-45Hz) frequency bands.
These PLV functional connectivity matrices will be used to construct weighted brain networks across a sparsity threshold range of 0.1 to 0.5.
Small-world propensity, a graph-theoretic metric evaluating the balance between local network specialization and global integration, will then be calculated and reported based on these PLV networks.
|
Day 1 (during the single experimental session)
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Xue-Juan Yang, Xidian University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 20260612
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .