Spinal Cord InjuryNCT07588711
Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Neuropathic Pain Following Spinal Cord Injury
A study testing Active Transcutaneous Auricular Vagus Nerve Stimulation in people with Spinal Cord Injury and Neuropathic 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 pilot randomized, double-blind, sham-controlled clinical investigation will evaluate the feasibility and safety of a 30-day home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention in adults with spinal cord injury (SCI) and neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Neuropathic 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 30 Aug 2028
- Phase
- Interventional
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
- SCI of any level or severity
- 18 years of age or older
- current neuropathic pain
- on no medications or on a stable prescribed dose (no change in prior 6-weeks) of anti-inflammatory, pain medications and/or depression medications
Who cannot join
- Prone to autonomic dysreflexia
- presence of cardiovascular disease
- pacemaker or other implanted electrical device
- cerebral shunts
- epilepsy
- pregnant or attempting to become pregnant
- current wound/infection
- unstable dose of prescribed anti-inflammatory, depression, or pain medications within past 6-weeks.
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, N6C0A7
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) as an Anti-inflammatory Strategy for the Treatment of Neuropathic Pain Following Spinal Cord Injury
This pilot randomized, double-blind, sham-controlled clinical investigation will evaluate the feasibility and safety of a 30-day home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention in adults with spinal cord injury (SCI) and neuropathic pain. Participants will be randomized to receive either active taVNS targeting the auricular branch of the vagus nerve or sham taVNS delivered to the earlobe. Primary outcomes include feasibility, safety, adherence, acceptability, and blinding success. Exploratory outcomes include changes in neuropathic pain, systemic inflammatory biomarkers, vagal tone assessed via heart rate variability, and quality of life.
Read the detailed description
Neuropathic pain is a common and debilitating complication following spinal cord injury (SCI) and is frequently resistant to pharmacologic treatment. Chronic neuroinflammation and reduced vagal tone are increasingly recognized contributors to persistent neuropathic pain after SCI. The vagus nerve plays a central role in immune regulation and descending pain modulation.
Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that stimulates vagal afferent fibers via the external ear. Prior Health Canada-authorized trials conducted by the investigative team have demonstrated the feasibility, safety, and autonomic effects of taVNS in individuals with SCI.
This single-site, randomized, double-blind, sham-controlled pilot study will enroll 32 adults with SCI and neuropathic pain. Participants will be randomized 1:1 to receive either active or sham taVNS for 4 hours per day over a 30-day home-based intervention period. Outcomes will be assessed at baseline and immediately post-intervention. Feasibility and safety outcomes are primary, while exploratory clinical and mechanistic outcomes will inform the design of a future definitive randomized controlled trial.
- Conditions
- Spinal Cord Injury, Neuropathic Pain
- Being tested
- Active Transcutaneous Auricular Vagus Nerve Stimulation, Sham Transcutaneous Auricular Vagus Nerve Stimulation
- Keywords
- vagus nerve stimulation, inflammation, spinal cord injury, neuropathic pain, taVNS
- Medical subject headings
- Spinal Cord Injuries, Neuralgia, Inflammation
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.
Recruitment Rate and Time to Recruit Target Sample Size
Recruitment feasibility will be assessed by documenting the number and proportion of eligible individuals who consent to participate and the total time required to recruit the target sample of 32 participants. Recruitment rate will be calculated as the percentage of eligible candidates who agree to participate. These data will be summarized descriptively for the overall study population.
Measured: Up to 20 months
Retention and Attrition During the 30-Day Intervention
Retention will be assessed as the proportion of enrolled participants who complete the full 30-day intervention and post-intervention assessment. Attrition will be recorded as the number and proportion of participants who withdraw prior to study completion. Reasons for withdrawal or loss to follow-up will be documented where available. Retention and attrition rates will be summarized and compared descriptively between the active taVNS and sham taVNS groups.
Measured: 30 days
Adherence to Daily taVNS Stimulation Prescription
Adherence will be assessed using automated usage data recorded by the taVNS device and associated smartphone application. Daily adherence will be calculated as the percentage of the prescribed 4-hour daily stimulation period completed (actual stimulation time divided by prescribed stimulation time × 100). Overall adherence will be summarized as the mean daily adherence across the 30-day intervention period. Adherence will be compared descriptively between the active taVNS and sham taVNS groups.
Measured: 30 days
Acceptability with the taVNS intervention
Participant acceptability will be assessed at the end of the intervention using the Acceptability of Intervention Measure (AIM). Acceptability scores will be summarized descriptively and compared between the active taVNS and sham taVNS conditions.
Measured: Day 30
Incidence of Treatment-Emergent Adverse Events During Intervention
All adverse events which occur during the intervention will be recorded during the twice weekly phone calls and/or study visits and compared between the active taVNS and sham taVNS conditions. A description of the adverse event, number of events, and total number of participants affected will be recorded.
Measured: 30 days
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
Secondary outcomes (9)
Change in Neuropathic Pain Assessed by the Neuropathic Pain Symptoms Inventory
Neuropathic pain severity and interference will be assessed using the Neuropathic Pain Symptoms Inventory (NPSI), a self-reported questionnaire with total scores ranging from 0 to 100, where higher scores indicate greater neuropathic pain severity and pain-related interference. Change scores will be calculated as post-intervention values minus baseline values. Mean changes and variability will be summarized and compared descriptively between the active taVNS and sham taVNS groups.
Measured: Baseline and Day 30
Change in Neuropathic Pain Assessed by the International Spinal Cord Injury Pain Basic Data Set (version 3)
Neuropathic pain severity and pain-related interference will be assessed using the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS), version 3, which includes numeric rating scales ranging from 0 to 10, where higher scores indicate greater pain intensity and greater pain-related interference. Change scores will be calculated as post-intervention values minus baseline values. Mean changes and variability will be summarized and compared descriptively 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
Change in Vagal Tone Assessed by Heart Rate Variability
Vagal tone will be assessed using heart rate variability (HRV) derived from a 5-minute resting electrocardiogram recording. Root mean square of successive differences (RMSSD) and high-frequency power will be calculated using standard HRV analysis procedures. Change in HRV measures from baseline to post-intervention will be summarized descriptively and compared between the active taVNS and sham taVNS groups.
Measured: Baseline and Day 30
Change in Health-Related Quality of Life
Quality of life will be assessed using selected short forms from the Spinal Cord Injury-Quality of Life (SCI-QOL) measurement system, including Pain Interference, Depression, and Positive Affect and Well-Being domains. Scores will be calculated as standardized T-scores. Change in quality-of-life scores from baseline to post-intervention will be summarized and compared descriptively between treatment groups.
Measured: Baseline and Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- 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 pilot study. Thirty-two adults with spinal cord injury and neuropathic 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 for 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 at the end of 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
- NCT07588711
- Sponsor's protocol ID
- ALLISON-03-2026
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No