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Combined Regulatory Effects of 40 Hz eTNS and Multisensory Stimulation on Brain Networks

2026年6月28日 更新者：Xidian University

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
    • Shaanxi
      • Xi'an、Shaanxi、中国、71000

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：基础科学
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：40 Hz External Trigeminal Nerve Stimulation
Electrical stimulation targeting the maxillary branch of the trigeminal nerve at a frequency of 40 Hz
设备：40 Hz Auditory Stimulation
Auditory sensory stimulation delivered at 40 Hz for 5-minute durations
设备：40 Hz Visual Stimulation
Visual sensory stimulation delivered at a frequency of 40 Hz for 5-minute durations
其他：Sham Stimulation
Inactive control stimulation designed to mimic the sensory experience of the active modalities without delivering actual 40 Hz therapeutic stimulation

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Whole-Brain Functional Connectivity (Phase-Locking Value)
大体时间：Day1 (during the single experimental session)
Day1 (during the single experimental session)

次要结果测量

结果测量
措施说明
大体时间
EEG Microstate Dynamics (Mean Duration and Segment Density)
大体时间：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
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Xidian University

合作者

Xi'an Central Hospital

调查人员

  • 首席研究员：Xue-Juan Yang、Xidian University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月16日

初级完成 (实际的)

2026年6月22日

研究完成 (估计的)

2026年6月23日

研究注册日期

首次提交

2026年6月12日

首先提交符合 QC 标准的

2026年6月21日

首次发布 (实际的)

2026年6月25日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月28日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 20260612

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data (IPD), particularly raw continuous electrophysiological recordings (EEG), contains sensitive and potentially identifiable biometric information. In accordance with institutional data security policies and ethical guidelines regarding participant privacy, raw IPD will not be made publicly available. However, aggregated statistical data and summary results will be published in peer-reviewed journals. De-identified, summary-level data or analytical scripts may be shared by the corresponding author upon reasonable academic request, subject to formal institutional review and approval.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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