Health TrialsbyHealthPanel

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

ConditionHealthy Participants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorXidian University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 40 Hz External Trigeminal Nerve Stimulation

    Device

    Electrical stimulation targeting the maxillary branch of the trigeminal nerve at a frequency of 40 Hz

  • 40 Hz Auditory Stimulation

    Device

    Auditory sensory stimulation delivered at 40 Hz for 5-minute durations

  • 40 Hz Visual Stimulation

    Device

    Visual sensory stimulation delivered at a frequency of 40 Hz for 5-minute durations

  • Sham Stimulation

    Other intervention

    Inactive control stimulation designed to mimic the sensory experience of the active modalities without delivering actual 40 Hz therapeutic stimulation

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental Crossover GroupExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Whole-Brain Functional Connectivity (Phase-Locking Value)

Time frame
Day1 (during the single experimental session)

Secondary outcomes

1

EEG Microstate Dynamics (Mean Duration and Segment Density)

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.

Time frame
Up to 1 hour (during the single experimental session)
2

EEG Phase-Locking Value (PLV)-Derived Global Efficiency

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.

Time frame
Day1 (during the single experimental session)
3

EEG Phase-Locking Value (PLV)-Derived Small-World Propensity

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.

Time frame
Day 1 (during the single experimental session)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xidian University

Lead sponsor

Xi'an Central Hospital

Collaborator

Source ClinicalTrials.gov
Apply now