TaVNS for Capsaicin-Induced Pain
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Transcutaneous Auricular Vagus Nerve Stimulation, Transcutaneous Auricular Vagus Nerve Stimulation.
- Кому может быть актуально
- Состояния в реестре: Pain Management, Capsaicin-Induced Pain, Transcranial Magnetic Stimulation Repetitive, Electroencephalography. Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Analgesic Efficacy and Neural Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation in a Capsaicin-Induced Pain Model
Обзор
Effective pain management remains a major clinical challenge. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising, non-invasive neuromodulation technique due to its safety, ease of administration, and cost-effectiveness. Preliminary evidence suggests that taVNS exerts analgesic effects by activating afferent vagal fibers, which integrate signals in key central nodes such as the nucleus tractus solitarius (NTS). This process subsequently modulates pain-processing networks, neurotransmitter balance, inflammatory responses, and autonomic function. Despite its potential, the precise central neural mechanisms underlying taVNS-induced analgesia remain unclear, limiting the optimization of stimulation parameters (e.g., intensity, frequency, and target specificity) and the enhancement of long-term therapeutic outcomes. Previous studies have highlighted the role of taVNS in activating descending pain inhibitory pathways and modulating the limbic system, yet a comprehensive understanding of the causal neurophysiological dynamics is still lacking. This study aims to investigate the analgesic efficacy of taVNS using a capsaicin-induced pain model. Furthermore, by employing Transcranial Magnetic Stimulation combined with Electroencephalography (TMS-EEG), we seek to elucidate the central neural mechanisms of taVNS. By integrating causal intervention with high-temporal resolution brain activity recording, this research will provide scientific insights into the modulation of pain-related pathways-such as descending inhibitory and cognitive-affective networks-ultimately facilitating the development of standardized, individualized, and precise clinical interventions for pain management.
Вмешательства
- Устройство Transcutaneous Auricular Vagus Nerve Stimulation
Participants receive taVNS using a percutaneous electrical stimulation device. The stimulation is delivered to the auricular branch of the vagus nerve via two modified punctate electrodes with the following parameters: frequency = 30 Hz, pulse width = 200 μs, duration = 30 minutes. - Устройство Transcutaneous Auricular Vagus Nerve Stimulation
Participants receive sham stimulation via the same device, with parameters set to 0.1 Hz for 30 minutes, designed to provide minimal sensory input that is indistinguishable from the active stimulation to ensure double-blinding.
Первичные конечные точки
- Pain Intensity [Срок оценки: Baseline and every 10 minutes up to 90 minutes post-capsaicin application.]
Вторичные конечные точки (4)
- Neural Plasticity and Brain Activity [Срок оценки: Baseline (pre-intervention), 40 minutes, and 90 minutes post-capsaicin application.]
- Brain Network Connectivity [Срок оценки: Baseline (pre-intervention), 40 minutes, and 90 minutes post-capsaicin application.]
- Pain-Related Emotional States [Срок оценки: From baseline through 90 minutes post-capsaicin application, assessed every 10 minutes.]
- Pain-Related Cognitive States [Срок оценки: At baseline, 40 minutes post-capsaicin, and 90 minutes post-capsaicin.]
Критерии участия
Критерии включения
\- 1. Adults aged 18 to 65 years. 2. Physically and mentally healthy individuals with no history of chronic pain (confirmed via clinical interviews and the MINI International Neuropsychiatric Interview).
3\. Right-handed.
Критерии исключения
- 1\. Presence of metallic implants (e.g., cardiac pacemakers) or other conditions precluding vagus nerve stimulation.
2\. Diagnosis of psychiatric disorders or presence of suicidal ideation. 3. History of epilepsy. 4. History of drug or substance abuse/dependence. 5. Known allergy to capsaicin or its vehicle solutions. 6. Inability to understand or respond to study-related questions.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07719868 · 2025-1505