Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy
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: Active Transcutaneous Auricular Vagus Nerve Stimulation, Sham Transcutaneous Auricular Vagus Nerve Stimulation.
- Кому может быть актуально
- Состояния в реестре: Cerebral Palsy (CP), Musculoskeletal Pain. Базовые параметры: от 18 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
- Канада
- 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
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Chronic Musculoskeletal (MSK) Pain in Adults With Cerebral Palsy
Обзор
This randomized, double-blind, sham-controlled clinical trial will evaluate the safety and efficacy of a 30-day home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention in adults with cerebral palsy (CP) and chronic musculoskeletal pain. Participants will be randomized to receive either active taVNS targeting the auricular branch of the vagus nerve or sham stimulation delivered to the earlobe. The primary outcomes are changes in musculoskeletal pain severity and pain interference, as well as safety assessed through treatment-emergent adverse events. Exploratory outcomes include health-related quality of life, depression, fatigue, spasticity, systemic inflammatory biomarkers, and blinding success.
Подробное описание
Chronic musculoskeletal pain is highly prevalent among adults with cerebral palsy (CP) and represents a major contributor to disability, reduced quality of life, and psychological distress. Pain in CP is often persistent, multifactorial, and inadequately controlled with available pharmacologic and rehabilitative treatments. Emerging evidence suggests that chronic low-grade inflammation, altered autonomic regulation, and disrupted central pain modulation may contribute to pain persistence in this population.
The vagus nerve plays a key role in regulating descending inhibitory pain pathways and inflammation via the inflammatory reflex. Reduced vagal tone has been associated with chronic pain and mood disturbances, suggesting that interventions targeting vagal activity may offer therapeutic benefit. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that activates vagal afferent fibers via the external ear and has demonstrated safety and feasibility across multiple clinical populations.
This single-site, randomized, double-blind, sham-controlled clinical trial will enroll adults with CP and chronic musculoskeletal pain. Participants will be randomized in a 1:1 ratio to receive either active taVNS targeting the auricular branch of the vagus nerve or sham stimulation delivered to the earlobe. The intervention will consist of a 30-day home-based stimulation protocol. Outcomes will be assessed at baseline and immediately following the intervention period.
The primary outcomes of this study are changes in musculoskeletal pain severity and pain-related interference with daily activities, as well as safety as assessed by treatment-emergent adverse events. Secondary and exploratory outcomes include measures of health-related quality of life, mood, fatigue, spasticity, autonomic function assessed via heart rate variability, and systemic inflammatory biomarkers. Findings from this trial will inform the therapeutic potential of taVNS for chronic pain in adults with CP and support the design of future definitive randomized controlled trials.
Вмешательства
- Устройство Active Transcutaneous Auricular Vagus Nerve Stimulation
Stimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the tVNS R device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA (milliamps) until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expect - Устройство Sham Transcutaneous Auricular Vagus Nerve Stimulation
Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA). Pulse width will be set at 100μs and frequency will be set
Первичные конечные точки
- Change in Musculoskeletal Pain Assessed by the Brief Pain Inventory [Срок оценки: Baseline and Day 30]
- Change in Musculoskeletal Pain Assessed by the Numeric Pain Rating Scale [Срок оценки: Baseline and Day 30]
- Incidence of Treatment-Emergent Adverse Events During Intervention [Срок оценки: 30 days]
Вторичные конечные точки (11)
- Change in Health-Related Quality of Life (EQ-5D-5L) [Срок оценки: Baseline and Day 30]
- Change in Depressive Symptoms assessed by the Patient Health Questionnaire-9 [Срок оценки: Baseline and Day 30]
- Change in Depressive Symptoms assessed by the Hamilton Depression Rating Scale [Срок оценки: Baseline and Day 30]
- Change in Fatigue Severity and Impact assessed by the Fatigue Impact and Severity Self-Assessment [Срок оценки: Baseline and Day 30]
- Change in Spasticity Severity assessed by the Numeric Rating Scale [Срок оценки: Baseline and Day 30]
- Change in Circulating C-Reactive Protein [Срок оценки: Baseline and Day 30]
- Change in Circulating Interleukin-1 Beta [Срок оценки: Baseline and Day 30]
- Change in Circulating Interleukin-6 [Срок оценки: Baseline and Day 30]
- Change in Circulating Interferon Gamma [Срок оценки: Baseline and Day 30]
- Change in Circulating Tumor Necrosis Factor Alpha [Срок оценки: Baseline and Day 30]
- Success of Participant and Investigator Blinding [Срок оценки: Day 30]
Критерии участия
Критерии включения
- Diagnosis of cerebral palsy
- Age ≥18 years
- Chronic musculoskeletal pain present for ≥1 year
- Moderate or greater pain severity (≥4/10 on Numeric Pain Rating Scale)
- Stable pain and/or anti-inflammatory medication dosing for ≥6 weeks
Критерии исключения
- Cardiovascular disease
- Pacemaker or implanted electrical device
- Cerebral shunt
- Pregnancy or intent to become pregnant
- Current infection or open wounds at electrode sites
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Канада · 1 центр
- Parkwood Institute, St Joseph's Health Care London — London
Идентификаторы
NCT: NCT07585292 · ALLISON-04-2026