Frequency Effects of Transcutaneous Trigeminal Nerve Stimulation (eTNS) on Brain and Autonomic Function
21 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
25
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Xue-Juan Yang
- Número de telefone: 13227038185
- E-mail: xjyang@xidian.edu.cn
Locais de estudo
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Shaanxi
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Xi'an, Shaanxi, China, 71000
- Recrutamento
- Xidian University
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Contato:
- Xue-Juan Yang
- Número de telefone: 13227038185
- E-mail: xjyang@xidian.edu.cn
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Difference in Blood Oxygenation Level-Dependent (BOLD) Signal Amplitude in the Brainstem
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Functional Connectivity (FC) within and outside the Central Autonomic Network
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
6 de agosto de 2026
Conclusão Primária (Estimado)
20 de agosto de 2026
Conclusão do estudo (Estimado)
20 de agosto de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
15 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de junho de 2026
Primeira postagem (Real)
23 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
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Palavras-chave
Outros números de identificação do estudo
- 20260617
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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