Cerebral Palsy (CP)NCT07585292
Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Musculoskeletal Pain in Cerebral Palsy
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation in people with Cerebral Palsy (CP) and Musculoskeletal Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Palsy (CP), Musculoskeletal Pain
- What is being tested?
- Active Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2026to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiovascular disease
- Pacemaker or implanted electrical device
- Cerebral shunt
- Pregnancy or intent to become pregnant
- Current infection or open wounds at electrode sites
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Parkwood Institute, St Joseph's Health Care London
London, Ontario, N6C 0A7
David J. Allison, PhD, 519 646 6100 ext. 42570, David.Allison@sjhc.london.on.ca
Joy Jiang, 519 646 6100 ext. 42570, fjiang63@uwo.ca
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cerebral Palsy (CP), Musculoskeletal Pain
- Being tested
- Active Transcutaneous Auricular Vagus Nerve Stimulation, Sham Transcutaneous Auricular Vagus Nerve Stimulation
- Keywords
- vagus nerve stimulation, musculoskeletal pain, taVNS, cerebral palsy
- Medical subject headings
- Cerebral Palsy, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Transcutaneous Auricular Vagus Nerve StimulationDevice
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.
Sham Transcutaneous Auricular Vagus Nerve StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active taVNS | Experimental | 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. Receives: Device: Active Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham taVNS | Sham comparator | 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. Receives: Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 30 days
Secondary outcomes (11)
Change in Health-Related Quality of Life (EQ-5D-5L)
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.
Measured: Baseline and Day 30
Change in Depressive Symptoms assessed by the Patient Health Questionnaire-9
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.
Measured: Baseline and Day 30
Change in Depressive Symptoms assessed by the Hamilton Depression Rating Scale
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.
Measured: Baseline and Day 30
Change in Fatigue Severity and Impact assessed by the Fatigue Impact and Severity Self-Assessment
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.
Measured: Baseline and Day 30
Change in Spasticity Severity assessed by the Numeric Rating Scale
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.
Measured: Baseline and Day 30
Change in Circulating C-Reactive Protein
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.
Measured: Baseline and Day 30
Change in Circulating Interleukin-1 Beta
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.
Measured: Baseline and Day 30
Change in Circulating Interleukin-6
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.
Measured: Baseline and Day 30
Change in Circulating Interferon Gamma
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.
Measured: Baseline and Day 30
Change in Circulating Tumor Necrosis Factor Alpha
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.
Measured: Baseline and Day 30
Success of Participant and Investigator Blinding
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.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion28 Feb 2029 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, sham-controlled, parallel-group study. Thirty-two adults with cerebral palsy and chronic musculoskeletal pain will be randomized in a 1:1 ratio to receive either active transcutaneous auricular vagus nerve stimulation (taVNS) or sham taVNS. Following a baseline visit that includes eligibility confirmation, outcome assessments, and device training, participants will complete a 30-day home-based intervention during which they will use the assigned stimulation device for 4 hours per day. Outcomes will be assessed at baseline and immediately following the 30-day intervention period. Participants, investigators, care providers, and outcome assessors will remain blinded to treatment allocation throughout the study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585292
- Sponsor's protocol ID
- ALLISON-04-2026
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for the Treatment of Chronic Musculoskeletal (MSK) Pain in Adults With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07585292
- Acronym / sponsor ID
- ALLISON-04-2026
- Conditions
- Cerebral Palsy (CP), Musculoskeletal Pain
- Keywords
- vagus nerve stimulation, musculoskeletal pain, taVNS, cerebral palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, sham-controlled, parallel-group study. Thirty-two adults with cerebral palsy and chronic musculoskeletal pain will be randomized in a 1:1 ratio to receive either active transcutaneous auricular vagus nerve stimulation (taVNS) or sham taVNS. Following a baseline visit that includes eligibility confirmation, outcome assessments, and device training, participants will complete a 30-day home-based intervention during which they will use the assigned stimulation device for 4 hours per day. Outcomes will be assessed at baseline and immediately following the 30-day intervention period. Participants, investigators, care providers, and outcome assessors will remain blinded to treatment allocation throughout the study.
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Experimental | Device: Active Transcutaneous Auricular Vagus Nerve StimulationParticipants 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 comparator | Device: Sham Transcutaneous Auricular Vagus Nerve StimulationStimulation 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Cardiovascular disease
- Pacemaker or implanted electrical device
- Cerebral shunt
- Pregnancy or intent to become pregnant
- Current infection or open wounds at electrode sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Transcutaneous Auricular Vagus Nerve StimulationStimulation 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. | Device | Active taVNS |
| Sham Transcutaneous Auricular Vagus Nerve StimulationStimulation 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. | Device | Sham taVNS |
Primary outcome
Change in Musculoskeletal Pain Assessed by the Brief Pain Inventory
Time frame: 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.
Change in Musculoskeletal Pain Assessed by the Numeric Pain Rating Scale
Time frame: 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.
Incidence of Treatment-Emergent Adverse Events During Intervention
Time frame: 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.
11 secondary outcomes
Change in Health-Related Quality of Life (EQ-5D-5L)
Time frame: Baseline and Day 30
Change in Depressive Symptoms assessed by the Patient Health Questionnaire-9
Time frame: Baseline and Day 30
Change in Depressive Symptoms assessed by the Hamilton Depression Rating Scale
Time frame: Baseline and Day 30
Change in Fatigue Severity and Impact assessed by the Fatigue Impact and Severity Self-Assessment
Time frame: Baseline and Day 30
Change in Spasticity Severity assessed by the Numeric Rating Scale
Time frame: Baseline and Day 30
Change in Circulating C-Reactive Protein
Time frame: Baseline and Day 30
Change in Circulating Interleukin-1 Beta
Time frame: Baseline and Day 30
Change in Circulating Interleukin-6
Time frame: Baseline and Day 30
Change in Circulating Interferon Gamma
Time frame: Baseline and Day 30
Change in Circulating Tumor Necrosis Factor Alpha
Time frame: Baseline and Day 30
Success of Participant and Investigator Blinding
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation in people with Cerebral Palsy (CP) and Musculoskeletal Pain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David J Allison, PhD. (519 646 6100 ext. 42570, David.Allison@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Musculoskeletal Pain Assessed by the Brief Pain Inventory (time frame: Baseline and Day 30). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.