NCT06493071 Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Inflammation and Depression Following SCI
| NCT ID | NCT06493071 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Spinal Cord Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-01-27 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2025-01-27 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spinal cord injury (SCI) has been shown to be associated with impairment to the autonomic nervous system in the form of reduced activity of a key nerve known as the vagus nerve. As the vagus nerve has an important role in regulating inflammation and is associated with depression, it may represent a key mechanism which contributes to chronic inflammation and depression following SCI. A technique known as transcutaneous auricular vagus nerve stimulation (taVNS) can stimulate the vagus nerve non-invasively through an electrode applied on the skin of the ear. This technique has been shown to effectively reduce inflammation and improve symptoms of depression in other populations without any serious adverse events. However, it has not been assessed in individuals with SCI. The primary objective of this study is to assess the efficacy of taVNS therapy for the treatment of inflammation and depression. Autonomic function as assessed by measures of heart rate variability (HRV) will also be assessed to quantify changes in vagal tone. The study will be conducted over a 2-year period, with 44 individuals with SCI and depression participating. Participants will be randomly assigned to receive either active taVNS or a placebo (sham) treatment over a 30-day period. The researchers will assess changes in depression symptoms, autonomic function (heart rate variability), and biomarkers related to inflammation at baseline and 30-days. Safety and adherence will also be evaluated to confirm the feasibility for long-term use. This study aims to explore a novel and non-invasive treatment strategy for depression in individuals with spinal cord injury. If taVNS is found to be safe, effective, and feasible for SCI patients, it could offer a simple, cost-effective way to address chronic inflammation and depression in this population.
Eligibility Criteria
Inclusion criteria: 1. SCI of any level or severity 2. 18 years of age or older 3. scores suggesting mild - moderately severe depression on the PHQ-9 (5 - 19) 4. stable dose of depression medications Exclusion criteria: 1. Prone to autonomic dysreflexia 2. Severe depression as assessed by PHQ-9 (≥20) 3. Suicidal ideation 4. presence of cardiovascular disease 5. pacemaker or other implanted electrical device (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker) 6. people with cerebral shunts 7. people with epilepsy 8. people who pregnant or attempting to become pregnant.
Contact & Investigator
David J Allison, PhD.
PRINCIPAL INVESTIGATOR
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Frequently Asked Questions
Who can join the NCT06493071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06493071 currently recruiting?
Yes, NCT06493071 is actively recruiting participants. Contact the research team at David.Allison@sjhc.london.on.ca for enrollment information.
Where is the NCT06493071 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT06493071 clinical trial?
NCT06493071 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is David J Allison, PhD. at London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The trial plans to enroll 44 participants.