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

28 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

30

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 71000

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: 40 Hz External Trigeminal Nerve Stimulation
Electrical stimulation targeting the maxillary branch of the trigeminal nerve at a frequency of 40 Hz
Apparaat: 40 Hz Auditory Stimulation
Auditory sensory stimulation delivered at 40 Hz for 5-minute durations
Apparaat: 40 Hz Visual Stimulation
Visual sensory stimulation delivered at a frequency of 40 Hz for 5-minute durations
Ander: Sham Stimulation
Inactive control stimulation designed to mimic the sensory experience of the active modalities without delivering actual 40 Hz therapeutic stimulation

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Whole-Brain Functional Connectivity (Phase-Locking Value)
Tijdsspanne: Day1 (during the single experimental session)
Day1 (during the single experimental session)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
EEG Microstate Dynamics (Mean Duration and Segment Density)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xidian University

Medewerkers

Xi'an Central Hospital

Onderzoekers

  • Hoofdonderzoeker: Xue-Juan Yang, Xidian University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 juni 2026

Primaire voltooiing (Werkelijk)

22 juni 2026

Studie voltooiing (Geschat)

23 juni 2026

Studieregistratiedata

Eerst ingediend

12 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 juni 2026

Eerst geplaatst (Werkelijk)

25 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

28 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • 20260612

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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