Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy
2026年5月7日 更新者：London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Chronic Musculoskeletal (MSK) Pain in Adults With Cerebral Palsy
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.
研究概览
地位
尚未招聘
详细说明
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.
研究类型
介入性
注册 (估计的)
32
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：David J Allison, PhD.
- 电话号码：42570 519 646 6100
- 邮箱：David.Allison@sjhc.london.on.ca
研究联系人备份
- 姓名：Joy Jiang
- 电话号码：42570 519 646 6100
- 邮箱：fjiang63@uwo.ca
学习地点
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Ontario
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London、Ontario、加拿大、N6C 0A7
- Parkwood Institute, St Joseph's Health Care London
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接触：
- Joy Jiang
- 电话号码：42570 519 646 6100
- 邮箱：fjiang63@uwo.ca
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接触：
- David J. Allison, PhD
- 电话号码：42570 519 646 6100
- 邮箱：David.Allison@sjhc.london.on.ca
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cardiovascular disease
- Pacemaker or implanted electrical device
- Cerebral shunt
- Pregnancy or intent to become pregnant
- Current infection or open wounds at electrode sites
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Active taVNS
Participants receive active transcutaneous auricular vagus nerve stimulation delivered via the cymba conchae of the left ear using the using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days.
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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 (expected range based on prior studies 1 - 3.2mA).
Pulse width will be set at 100μs (microseconds) and frequency will be set at 25Hz (Hertz).
Parameters will be set for the duration of the intervention consisting of 4 hours of daily stimulation for a period of 30 days.
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假比较器：Sham taVNS
Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days.
Stimulation will be applied to the ear lobe in order to ensure participant feel the stimulation while avoiding activation of the vagus nerve.
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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 at 25Hz.
Participants will perform 4 hours of stimulation per day for a period of 30 days.
Stimulation will be applied to the ear lobe in order to ensure participant feel the stimulation while avoiding activation of the vagus nerve.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Musculoskeletal Pain Assessed by the Brief Pain Inventory
大体时间：Baseline and Day 30
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Musculoskeletal pain severity and pain interference will be assessed using the Brief Pain Inventory (BPI).
The BPI pain severity subscale evaluates pain intensity using four 0-10 numeric rating scale items assessing worst, least, average, and current pain.
A composite pain severity score will be calculated as the mean of these four items, in accordance with IMMPACT recommendations.
Pain interference will be assessed using the BPI interference subscale, which evaluates the extent to which pain interferes with general activity, mood, walking ability, normal work, relationships, sleep, and enjoyment of life using 0-10 numeric rating scales.
Higher scores indicate greater pain severity or interference.
Assessments will be conducted by trained outcome assessors blinded to group allocation.
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Baseline and Day 30
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Change in Musculoskeletal Pain Assessed by the Numeric Pain Rating Scale
大体时间：Baseline and Day 30
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Musculoskeletal pain severity will also be assessed using the Numeric Pain Rating Scale (NPRS), a simple and widely used self-report measure of pain intensity.
Participants will rate their average pain intensity on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain).
The NPRS will serve as a complementary, standardized measure of pain intensity to enhance the robustness and interpretability of pain assessment.
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Baseline and Day 30
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Incidence of Treatment-Emergent Adverse Events During Intervention
大体时间：30 days
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All treatment-emergent adverse events occurring during the intervention period will be recorded through weekly phone calls and/or study visits.
Adverse events will be summarized by type, frequency, severity, and relationship to the study intervention.
The number and proportion of participants experiencing at least one adverse event will be compared between the active taVNS and sham taVNS groups.
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30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Health-Related Quality of Life (EQ-5D-5L)
大体时间：Baseline and Day 30
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Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L), a validated self-report measure of health status.
The EQ-5D-5L assesses five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across five levels of severity.
Change in health-related quality of life from baseline to the end of the 30-day intervention period will be compared between the active taVNS and sham taVNS groups.
Higher index values and visual analogue scale scores indicate better health status.
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Baseline and Day 30
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Change in Depressive Symptoms assessed by the Patient Health Questionnaire-9
大体时间：Baseline and Day 30
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Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated self-report questionnaire that measures the severity of depressive symptoms experienced over the past two weeks.
Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Change in PHQ-9 scores from baseline to the end of the 30-day intervention period will be compared between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Change in Depressive Symptoms assessed by the Hamilton Depression Rating Scale
大体时间：Baseline and Day 30
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Depressive symptoms will be assessed using the Hamilton Depression Rating Scale (HAM-D), a clinician-administered measure of depression severity.
The HAM-D will be completed by a trained assessor blinded to group allocation.
Higher scores indicate greater depressive symptom severity.
Change in HAM-D scores from baseline to the end of the 30-day intervention period will be compared between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Change in Fatigue Severity and Impact assessed by the Fatigue Impact and Severity Self-Assessment
大体时间：Baseline and Day 30
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Fatigue will be assessed using the Fatigue Impact and Severity Self-Assessment (FISSA), a self-report questionnaire developed for individuals with cerebral palsy.
The FISSA includes 31 items assessing fatigue severity, the impact of fatigue on daily activities, and fatigue management behaviors.
Items are rated on a five-point Likert scale, with higher scores indicating greater fatigue severity and impact.
Change in fatigue from baseline to the end of the 30-day intervention period will be evaluated using the FISSA total score and compared between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Change in Spasticity Severity assessed by the Numeric Rating Scale
大体时间：Baseline and Day 30
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Spasticity will be assessed using a patient-reported Numeric Rating Scale (NRS).
Participants will rate the severity of their spasticity over the past 24 hours on an 11-point scale ranging from 0 (no spasticity) to 10 (worst possible spasticity).
Higher scores indicate greater spasticity severity.
Change in spasticity severity from baseline to the end of the 30-day intervention period will be compared between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Change in Circulating C-Reactive Protein
大体时间：Baseline and Day 30
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Plasma concentrations of C-reactive protein (CRP) will be measured from fasting blood samples collected at baseline and at the end of the intervention.
Concentrations will be reported in milligrams per liter (mg/L), with higher values indicating greater systemic inflammation.
Change values will be calculated as post-intervention values minus baseline values and summarized descriptively between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Change in Circulating Interleukin-1 Beta
大体时间：Baseline and Day 30
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Plasma concentrations of interleukin-1 beta (IL-1β) will be measured from fasting blood samples collected at baseline and at the end of the intervention.
Concentrations will be reported in picograms per milliliter (pg/mL), with higher values indicating greater pro-inflammatory activity.
Change values will be calculated as post-intervention values minus baseline values and summarized descriptively between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Change in Circulating Interleukin-6
大体时间：Baseline and Day 30
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Plasma concentrations of interleukin-6 (IL-6) will be measured from fasting blood samples collected at baseline and at the end of the intervention.
Concentrations will be reported in picograms per milliliter (pg/mL), with higher values indicating greater pro-inflammatory activity.
Change values will be calculated as post-intervention values minus baseline values and summarized descriptively between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Change in Circulating Interferon Gamma
大体时间：Baseline and Day 30
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Plasma concentrations of interferon gamma (IFN-γ) will be measured from fasting blood samples collected at baseline and at the end of the intervention.
Concentrations will be reported in picograms per milliliter (pg/mL), with higher values indicating greater pro-inflammatory activity.
Change values will be calculated as post-intervention values minus baseline values and summarized descriptively between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Change in Circulating Tumor Necrosis Factor Alpha
大体时间：Baseline and Day 30
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Plasma concentrations of tumor necrosis factor alpha (TNF-α) will be measured from fasting blood samples collected at baseline and at the end of the intervention.
Concentrations will be reported in picograms per milliliter (pg/mL), with higher values indicating greater pro-inflammatory activity.
Change values will be calculated as post-intervention values minus baseline values and summarized descriptively between the active taVNS and sham taVNS groups.
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Baseline and Day 30
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Success of Participant and Investigator Blinding
大体时间：Day 30
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Blinding success will be assessed after completion of the intervention by asking participants and investigators to indicate which treatment group they believe the participant was assigned to (active taVNS or sham taVNS).
Blinding effectiveness will be quantified using the James Blinding Index, calculated separately for participants and investigators.
Blinding outcomes will be summarized descriptively.
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Day 30
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年10月1日
初级完成 (估计的)
2029年2月28日
研究完成 (估计的)
2029年5月31日
研究注册日期
首次提交
2026年5月7日
首先提交符合 QC 标准的
2026年5月7日
首次发布 (实际的)
2026年5月13日
研究记录更新
最后更新发布 (实际的)
2026年5月13日
上次提交的符合 QC 标准的更新
2026年5月7日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.