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Frequency Effects of Transcutaneous Trigeminal Nerve Stimulation (eTNS) on Brain and Autonomic Function

2026年6月21日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

25

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 中国
    • Shaanxi
      • Xi'an、Shaanxi、中国、71000
        • 募集
        • Xidian University
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

はい

説明

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. Contraindications to MRI scanning (e.g., claustrophobia, cardiac pacemakers, artificial cochlea, metallic braces, or any other ferromagnetic implants).
  2. Female participants who are pregnant, lactating, or suspect they might be pregnant.
  3. 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).
  4. 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).
  5. History of substance abuse, heavy smoking, or excessive daily consumption of alcohol or caffeine.
  6. Irregular sleep patterns, shift work, or severe sleep deprivation within 24 hours prior to the scanning session.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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).
デバイス：2Hz Transcutaneous Trigeminal Nerve Stimulation
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).
実験的：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).
デバイス：120Hz Transcutaneous Trigeminal Nerve Stimulation
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).
偽コンパレータ：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.
デバイス：Sham Transcutaneous Trigeminal Nerve Stimulation
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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Difference in Blood Oxygenation Level-Dependent (BOLD) Signal Amplitude in the Brainstem
時間枠：During the 7-minute and 30-second fMRI scan for each stimulation condition.
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.
During the 7-minute and 30-second fMRI scan for each stimulation condition.

二次結果の測定

結果測定
メジャーの説明
時間枠
Functional Connectivity (FC) within and outside the Central Autonomic Network
時間枠：During the 7-minute and 30-second fMRI scan for each stimulation condition.
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.
During the 7-minute and 30-second fMRI scan for each stimulation condition.
Change in Heart Rate Variability Assessed by Low Frequency to High Frequency (LF/HF) Ratio
時間枠：Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
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.
Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
Change in Respiratory Rate
時間枠：Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
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.
Continuously recorded during the 7-minute and 30-second fMRI scan for each stimulation condition.
Central-Autonomic Coupling Index
時間枠：Computed from data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.
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.
Computed from data acquired during the 7-minute and 30-second fMRI scan for each stimulation condition.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Xidian University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年8月6日

一次修了 (推定)

2026年8月20日

研究の完了 (推定)

2026年8月20日

試験登録日

最初に提出

2026年6月15日

QC基準を満たした最初の提出物

2026年6月21日

最初の投稿 (実際)

2026年6月23日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月23日

QC基準を満たした最後の更新が送信されました

2026年6月21日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 20260617

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