Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2026
CompletedFirst Posted
Study publicly available on registry
May 13, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2029
Study Completion
Last participant's last visit for all outcomes
May 31, 2029
May 13, 2026
May 1, 2026
2.4 years
May 7, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Musculoskeletal Pain Assessed by the Brief Pain Inventory
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
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
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
Secondary Outcomes (11)
Change in Health-Related Quality of Life (EQ-5D-5L)
Baseline and Day 30
Change in Depressive Symptoms assessed by the Patient Health Questionnaire-9
Baseline and Day 30
Change in Depressive Symptoms assessed by the Hamilton Depression Rating Scale
Baseline and Day 30
Change in Fatigue Severity and Impact assessed by the Fatigue Impact and Severity Self-Assessment
Baseline and Day 30
Change in Spasticity Severity assessed by the Numeric Rating Scale
Baseline and Day 30
- +6 more secondary outcomes
Study Arms (2)
Active taVNS
EXPERIMENTALParticipants 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.
Sham taVNS
SHAM COMPARATORStimulation 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Cardiovascular disease
- Pacemaker or implanted electrical device
- Cerebral shunt
- Pregnancy or intent to become pregnant
- Current infection or open wounds at electrode sites
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Parkwood Institute, St Joseph's Health Care London
London, Ontario, N6C 0A7, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 7, 2026
First Posted
May 13, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
February 28, 2029
Study Completion (Estimated)
May 31, 2029
Last Updated
May 13, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share