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Investigating the Transcutaneous vs. Transcranial Mechanisms of Trigeminal Nerve Stimulation (eTNS) Using fMRI

15 czerwca 2026 zaktualizowane przez: Xidian University

Differentiating the Transcutaneous and Transcranial Mechanisms of Direct Current Trigeminal Nerve Stimulation on Brainstem and Autonomic Function: A Randomized, Sham-Controlled, Crossover fMRI Study With Local Anesthesia

Transcutaneous Trigeminal Nerve Stimulation (eTNS) is a non-invasive technique that modulates brain activity by applying electrical currents to the forehead. However, it remains unclear whether its effects are primarily driven by activating peripheral nerves in the skin (the transcutaneous pathway) or by the electrical current passing directly through the skull into the brain (the transcranial pathway).

This study aims to differentiate these two mechanisms in healthy volunteers. Participants will complete two separate MRI scanning sessions. In one session, a local anesthetic (lidocaine) will be applied to numb the skin over the forehead (specifically the supraorbital nerve branch) to temporarily block the peripheral nerve signals. In the other session, no anesthesia will be used. During both sessions, participants will receive active direct current eTNS (DC-eTNS) and a sham (inactive) stimulation while inside a 3T MRI scanner.

Researchers will simultaneously measure brain activity (fMRI) and physiological signals (breathing and heart rate). By comparing the brain and bodily responses between the anesthetized and non-anesthetized conditions, the study seeks to determine exactly how eTNS signals travel to and affect the brainstem, cortex, and autonomic nervous system.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is an exploratory, randomized, sham-controlled, crossover functional neuroimaging study designed to isolate and differentiate the transcutaneous (peripheral nerve mediated) versus transcranial (direct electrical penetration) mechanisms of direct current Trigeminal Nerve Stimulation (DC-eTNS).

Healthy participants will undergo two separate study sessions in a randomized order:

Anesthesia Condition: Local anesthesia (Lidocaine) will be applied to the skin area corresponding to the supraorbital branch of the trigeminal nerve to temporarily block somatosensory afferent pathways.

No-Anesthesia Condition: The participant will undergo the same procedures without the application of local anesthesia.

During each session, participants will be scanned in a 3T MRI scanner. The imaging protocol will consist of a high-resolution structural T1-weighted scan, followed by two functional Blood Oxygenation Level-Dependent (BOLD) sequences: one for active DC-eTNS and one for Sham stimulation. Each functional BOLD sequence will last for 7 minutes and 30 seconds. The active DC-eTNS stimulation paradigm includes a 15-second current ramp-up phase at the beginning and a 15-second current ramp-down phase at the end to ensure participant comfort and safety.

Concurrently with the fMRI acquisition, continuous physiological monitoring will be conducted using a respiratory belt and a photoplethysmography (PPG) finger sensor to capture peripheral autonomic nervous system metrics.

Data Analysis Plan:

Primary Analysis: The primary objective is to evaluate the Amplitude of Low-Frequency Fluctuations (ALFF) specifically within the brainstem, focusing on the principal nodes of the trigeminal nerve. The core statistical comparison will assess the contrast of (DC-eTNS - Sham) under the No-Anesthesia condition versus (DC-eTNS - Sham) under the Anesthesia condition.

Secondary Analyses: Secondary neuroimaging analyses will investigate changes in dynamic and static functional connectivity between the brainstem nuclei and cortical regions, as well as whole-brain cortical activation disparities between the two sensory states.

Physiological and Coupling Analyses: Concurrent respiratory and PPG data will be analyzed to detect variations in autonomic nervous system activity (e.g., Heart Rate Variability). Furthermore, central-autonomic coupling indices will be calculated to examine how the different transmission pathways of DC-eTNS modulate the synchronization between central neural networks and peripheral autonomic output.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

25

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • Shaanxi
      • Xi'an, Shaanxi, Chiny, 71000
        • Rekrutacyjny
        • Xidian University
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  1. Healthy volunteers, aged 18 to 40 years old.
  2. Right-handed.
  3. Generally healthy with no history of neurological, psychiatric, or severe cardiovascular diseases.
  4. Normal physical and neurological examinations.
  5. Capable of understanding the study procedures and voluntarily signing the written informed consent form.

Exclusion Criteria:

  1. Known allergy, hypersensitivity, or adverse reactions to Lidocaine or other amide-type local anesthetics. (Crucial for this specific study design)
  2. Contraindications to MRI scanning (e.g., claustrophobia, cardiac pacemakers, artificial cochlea, metallic braces, or any other ferromagnetic implants).
  3. Female participants who are pregnant, lactating, or suspect they might be pregnant.
  4. Contraindications to transcranial or transcutaneous electrical stimulation (e.g., personal or family history of epilepsy/seizures, implanted brain stimulators).
  5. Any active skin disease, inflammation, lesions, cuts, or abrasions on the forehead (specifically over the supraorbital area), which could alter electrical impedance or anesthetic absorption.
  6. History of trigeminal neuralgia, facial nerve palsy, or chronic facial pain. Current or recent (within the past month) use of any medications known to affect the central nervous system, autonomic nervous system, or pain perception (e.g., analgesics, antidepressants, beta-blockers, or sedatives).
  7. History of substance abuse, heavy smoking, or excessive daily consumption of alcohol or caffeine.
  8. Irregular sleep patterns, shift work, or severe sleep deprivation within 24 hours prior to the scanning sessions.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Podstawowa nauka
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Lidocaine Anesthesia Session
In this crossover phase, participants will have a local anesthetic (Lidocaine) applied to the skin over the supraorbital branch of the trigeminal nerve to temporarily block somatosensory afferent pathways. Following the anesthesia, participants will undergo a 3T fMRI scan, during which they will receive both active Direct Current eTNS (DC-eTNS) and a Sham stimulation. Each stimulation sequence lasts for 7 minutes and 30 seconds.
Lek: Topical Lidocaine
Application of a local anesthetic over the forehead targeting the supraorbital nerve branch prior to the MRI scan, intended to block peripheral transcutaneous nerve conduction.
Urządzenie: Direct Current eTNS (DC-eTNS)
Active direct current electrical stimulation applied via electrodes on the forehead. The stimulation is synchronized with a 7-minute and 30-second BOLD fMRI sequence, which includes a 15-second current ramp-up phase at the beginning and a 15-second current ramp-down phase at the end.
Urządzenie: Sham DC-eTNS
An inactive or sensory-matched sham stimulation administered during a 7-minute and 30-second BOLD fMRI sequence to serve as a baseline comparator.
Aktywny komparator: No-Anesthesia Session
In this crossover phase, participants will NOT receive any local anesthesia. They will undergo the 3T fMRI scan with intact somatosensory pathways. Similar to the other arm, they will receive both active Direct Current eTNS (DC-eTNS) and a Sham stimulation. Each stimulation sequence lasts for 7 minutes and 30 seconds.
Urządzenie: Direct Current eTNS (DC-eTNS)
Active direct current electrical stimulation applied via electrodes on the forehead. The stimulation is synchronized with a 7-minute and 30-second BOLD fMRI sequence, which includes a 15-second current ramp-up phase at the beginning and a 15-second current ramp-down phase at the end.
Urządzenie: Sham DC-eTNS
An inactive or sensory-matched sham stimulation administered during a 7-minute and 30-second BOLD fMRI sequence to serve as a baseline comparator.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Amplitude of Low-Frequency Fluctuations (ALFF) in the Brainstem
Ramy czasowe: Computed from the data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.
The primary neuroimaging metric is the ALFF of the BOLD signal, specifically targeting the brainstem regions that encompass the primary nodes of the trigeminal nerve. To differentiate the transcutaneous and transcranial mechanisms, the core statistical analysis will evaluate the interaction effect by comparing the ALFF contrast of (DC-eTNS minus Sham) in the No-Anesthesia condition against the contrast of (DC-eTNS minus Sham) in the Anesthesia (Lidocaine) condition.
Computed from the data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Brainstem-to-Cortex Functional Connectivity
Ramy czasowe: Computed from the data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.
The strength of functional connectivity between the targeted brainstem nuclei and widespread cortical regions. Connectivity maps will be calculated and compared between the Anesthesia and No-Anesthesia conditions across the active DC-eTNS and Sham phases to evaluate how blocking peripheral pathways alters neural network communication.
Computed from the data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.
Whole-Brain Cortical Activation Levels
Ramy czasowe: During the 7-minute and 30-second fMRI scan for each stimulation condition.
Differences in whole-brain BOLD signal activation and deactivation patterns. This will assess the overall cortical response to DC-eTNS and determine how these activation levels are modulated when the peripheral somatosensory afferent pathways are temporarily blocked by local anesthesia.
During the 7-minute and 30-second fMRI scan for each stimulation condition.
Autonomic Nervous System (ANS) Activity Metrics
Ramy czasowe: Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
Peripheral autonomic physiological changes assessed via continuous respiratory belt and photoplethysmography (PPG) signals. Key parameters include Heart Rate Variability (HRV) indices (e.g., LF/HF ratio, RMSSD) and respiratory amplitude/rate. The variations in these metrics will be compared between the Anesthesia and No-Anesthesia states during DC-eTNS and Sham.
Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
Central-Autonomic Coupling Index
Ramy czasowe: Computed from the multi-modal data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.
The degree of synchronization (coupling) between central neural activity (BOLD signal fluctuations in brainstem/cortical regions) and peripheral autonomic outputs (HRV and respiratory signals). This metric aims to reveal whether the transcutaneous or transcranial pathway is the primary driver of central-autonomic integration during DC-eTNS.
Computed from the multi-modal data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Xidian University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

21 czerwca 2026

Zakończenie podstawowe (Szacowany)

5 lipca 2026

Ukończenie studiów (Szacowany)

5 lipca 2026

Daty rejestracji na studia

Pierwszy przesłany

15 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

18 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20260618

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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