Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Neuropathic Pain Following Sp… (NCT07588711) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Neuropathic Pain Following Spinal Cord Injury
Canada32 participantsStarted 2026-10-01
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Recruitment Rate and Time to Recruit Target Sample Size
Timeframe: Up to 20 months
2
Retention and Attrition During the 30-Day Intervention
Timeframe: 30 days
3
Adherence to Daily taVNS Stimulation Prescription
Timeframe: 30 days
4
Acceptability with the taVNS intervention
Timeframe: Day 30
5
Incidence of Treatment-Emergent Adverse Events During Intervention
Timeframe: 30 days
6
Success of Participant and Investigator Blinding
Timeframe: Day 30
Trial details
NCT IDNCT07588711
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's