Frequency Effects of Transcutaneous Trigeminal Nerve Stimulation (eTNS) on Brain and Autonomic Function
21 de junio de 2026 actualizado por: Xidian University
A Randomized, Sham-Controlled, Crossover fMRI Study on the Frequency Effects of Transcutaneous Trigeminal Nerve Stimulation on Central-Autonomic Coupling in Healthy Subjects
This study aims to investigate how different frequencies of transcutaneous Trigeminal Nerve Stimulation (eTNS) affect brain activity and the autonomic nervous system in healthy individuals.
Participants will undergo a 3T functional magnetic resonance imaging (fMRI) scan while receiving three different types of nerve stimulation: 2Hz eTNS, 120Hz eTNS, and a sham (inactive) stimulation.
The order of these stimulations will be randomly assigned.
During the brain scan, researchers will simultaneously monitor the participants' breathing and heart rhythms (using a finger sensor).
The main goal is to understand how changing the frequency of eTNS influences the connection between the brain's networks and the body's unconscious physiological responses.
Descripción general del estudio
Estado
Reclutamiento
Descripción detallada
This is an exploratory, randomized, sham-controlled, within-subject crossover fMRI study designed to evaluate the frequency-dependent effects of transcutaneous Trigeminal Nerve Stimulation (eTNS) on central-autonomic coupling in healthy volunteers.
Participants will undergo functional neuroimaging in a 3T MRI scanner. The imaging protocol consists of a structural T1-weighted scan and three functional Blood Oxygenation Level-Dependent (BOLD) sequences corresponding to three intervention arms: 2Hz-eTNS, 120Hz-eTNS, and Sham stimulation. The order of the three stimulation conditions will be randomized for each participant. To minimize potential carryover effects, the structural T1 scan will be acquired between the two active (real) stimulation sequences.
Each functional BOLD sequence will last for 7 minutes and 30 seconds and will utilize a block design. This design consists of alternating 30-second "ON" blocks (where the stimulation is active) and 30-second "OFF" blocks (where the stimulation is inactive).
Concurrently with the fMRI acquisition, continuous physiological monitoring will be conducted. This includes recording respiratory effort and photoplethysmography (PPG) via a finger pulse oximeter to capture peripheral autonomic metrics.
The primary and secondary analyses will focus on quantifying BOLD signal responses, evaluating dynamic changes in brain functional connectivity, assessing variations in autonomic nervous system metrics (such as heart rate variability derived from the PPG), and exploring the mechanisms of central-autonomic coupling across the different stimulation frequencies.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
25
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xue-Juan Yang
- Número de teléfono: 13227038185
- Correo electrónico: xjyang@xidian.edu.cn
Ubicaciones de estudio
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Shaanxi
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Xi'an, Shaanxi, Porcelana, 71000
- Reclutamiento
- Xidian University
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Contacto:
- Xue-Juan Yang
- Número de teléfono: 13227038185
- Correo electrónico: xjyang@xidian.edu.cn
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Healthy volunteers, aged 18 to 40 years old.
- Right-handed.
- Generally healthy with no history of neurological, psychiatric, or severe cardiovascular diseases.
- Normal physical and neurological examinations.
- Capable of understanding the study procedures and voluntarily signing the written informed consent form.
Exclusion Criteria:
- Contraindications to MRI scanning (e.g., claustrophobia, cardiac pacemakers, artificial cochlea, metallic braces, or any other ferromagnetic implants).
- Female participants who are pregnant, lactating, or suspect they might be pregnant.
- Contraindications to transcutaneous electrical stimulation (e.g., personal or family history of epilepsy/seizures, trigeminal neuralgia, facial skin lesions, or active skin diseases on the forehead).
- Current or recent (within the past month) use of any medications known to affect the central nervous system or the autonomic nervous system (e.g., antidepressants, beta-blockers, sedatives, or sympathomimetics).
- History of substance abuse, heavy smoking, or excessive daily consumption of alcohol or caffeine.
- Irregular sleep patterns, shift work, or severe sleep deprivation within 24 hours prior to the scanning session.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 2Hz-eTNS Condition
In this crossover phase, participants will receive 2Hz transcutaneous Trigeminal Nerve Stimulation (eTNS) during the 3T fMRI scan.
The stimulation will be delivered during a 7-minute and 30-second BOLD sequence using a block design, which alternates between 30-second "ON" periods (active 2Hz stimulation) and 30-second "OFF" periods (no stimulation).
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Active electrical stimulation applied over the skin of the forehead targeting the branches of the trigeminal nerve.
The stimulation frequency is set at 2Hz.
It is synchronized with the fMRI sequence and continuous physiological monitoring (respiration and photoplethysmography).
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Experimental: 120Hz-eTNS Condition
In this crossover phase, participants will receive 120Hz transcutaneous Trigeminal Nerve Stimulation (eTNS) during the 3T fMRI scan.
Similar to other active conditions, the stimulation will be delivered during a 7-minute and 30-second BOLD sequence using a block design, alternating between 30-second "ON" periods (active 120Hz stimulation) and 30-second "OFF" periods (no stimulation).
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Active electrical stimulation applied over the skin of the forehead targeting the branches of the trigeminal nerve.
The stimulation frequency is set at 120Hz.
It is synchronized with the fMRI sequence and continuous physiological monitoring (respiration and photoplethysmography).
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Comparador falso: Sham-eTNS Condition
In this crossover phase, participants will undergo the same fMRI scanning procedure and wear the exact same electrode pads as the active conditions, but will receive a sham stimulation.
This phase also lasts for 7 minutes and 30 seconds and utilizes a simulated 30-second "ON" / 30-second "OFF" block design to maintain double-blinding.
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An inactive or sensory-matched sham electrical stimulation designed to mimic the physical sensation of the device being active without delivering the therapeutic frequencies (2Hz or 120Hz).
It is administered synchronously with the fMRI BOLD sequence and physiological monitoring to serve as a baseline comparator.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Difference in Blood Oxygenation Level-Dependent (BOLD) Signal Amplitude in the Brainstem
Periodo de tiempo: During the 7-minute and 30-second fMRI scan for each stimulation condition.
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The metric is the percent signal change in BOLD amplitude within predefined Regions of Interest (ROIs) of the brainstem (e.g., trigeminal nuclei, locus coeruleus, nucleus tractus solitarii).
It is calculated as the BOLD signal difference between the 30-second stimulation "ON" blocks and the 30-second "OFF" blocks.
Data will be aggregated as the mean percentage of BOLD signal change for each stimulation condition.
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During the 7-minute and 30-second fMRI scan for each stimulation condition.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Functional Connectivity (FC) within and outside the Central Autonomic Network
Periodo de tiempo: During the 7-minute and 30-second fMRI scan for each stimulation condition.
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The strength of dynamic and static functional connectivity between key nodes of the CAN and other whole-brain regions.
Connectivity matrices will be computed and compared across the 2Hz-eTNS, 120Hz-eTNS, and Sham conditions to evaluate how different stimulation frequencies modulate brain network communications.
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During the 7-minute and 30-second fMRI scan for each stimulation condition.
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Change in Heart Rate Variability Assessed by Low Frequency to High Frequency (LF/HF) Ratio
Periodo de tiempo: Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
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The LF/HF ratio is a frequency-domain measure of heart rate variability derived from PPG data, reflecting the sympathovagal balance.
Data will be aggregated as the mean LF/HF ratio during each stimulation condition.
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Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
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Change in Respiratory Rate
Periodo de tiempo: Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
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Respiratory rate is extracted from concurrent respiratory belt signals to assess respiratory patterns.
Data will be aggregated as the mean respiratory rate (measured in breaths per minute) during each stimulation condition.
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Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
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Central-Autonomic Coupling Index
Periodo de tiempo: Computed from data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.
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The degree of synchronization between central neural activity and peripheral autonomic output.
This will be quantified by calculating the correlation coefficients or mutual information between the low-frequency fluctuations of the BOLD signals in CAN regions and the concurrent peripheral autonomic time-series data (HRV and respiration).
The coupling strength will be compared between the 2Hz and 120Hz conditions.
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Computed from data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
6 de agosto de 2026
Finalización primaria (Estimado)
20 de agosto de 2026
Finalización del estudio (Estimado)
20 de agosto de 2026
Fechas de registro del estudio
Enviado por primera vez
15 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
21 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
21 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 20260617
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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