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.
調査の概要
状態
まだ募集していません
詳細な説明
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.
研究の種類
介入
入学 (推定)
32
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
- 名前：David J Allison, PhD.
- 電話番号：42570 519 646 6100
- メール：David.Allison@sjhc.london.on.ca
研究連絡先のバックアップ
- 名前：Joy Jiang
- 電話番号：42570 519 646 6100
- メール：fjiang63@uwo.ca
研究場所
-
-
Ontario
-
London、Ontario、カナダ、N6C 0A7
- Parkwood Institute, St Joseph's Health Care London
-
コンタクト：
- Joy Jiang
- 電話番号：42570 519 646 6100
- メール：fjiang63@uwo.ca
-
コンタクト：
- David J. Allison, PhD
- 電話番号：42570 519 646 6100
- メール：David.Allison@sjhc.london.on.ca
-
-
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
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
偽コンパレータ：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.
|
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.
|
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 |
|---|---|---|
|
Change in Musculoskeletal Pain Assessed by the Brief Pain Inventory
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Musculoskeletal Pain Assessed by the Numeric Pain Rating Scale
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Incidence of Treatment-Emergent Adverse Events During Intervention
時間枠：30 days
|
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.
|
30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Health-Related Quality of Life (EQ-5D-5L)
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Depressive Symptoms assessed by the Patient Health Questionnaire-9
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Depressive Symptoms assessed by the Hamilton Depression Rating Scale
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Fatigue Severity and Impact assessed by the Fatigue Impact and Severity Self-Assessment
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Spasticity Severity assessed by the Numeric Rating Scale
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Circulating C-Reactive Protein
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Circulating Interleukin-1 Beta
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Circulating Interleukin-6
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Circulating Interferon Gamma
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Change in Circulating Tumor Necrosis Factor Alpha
時間枠：Baseline and Day 30
|
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.
|
Baseline and Day 30
|
|
Success of Participant and Investigator Blinding
時間枠：Day 30
|
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.
|
Day 30
|
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。
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10月1日
一次修了 (推定)
2029年2月28日
研究の完了 (推定)
2029年5月31日
試験登録日
最初に提出
2026年5月7日
QC基準を満たした最初の提出物
2026年5月7日
最初の投稿 (実際)
2026年5月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月13日
QC基準を満たした最後の更新が送信されました
2026年5月7日
最終確認日
2026年5月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。