Non-invasive vagus nerve stimulation for inflammation and depression after spinal cord injury
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) as an Anti-inflammatory Strategy for the Treatment of Depression Following Spinal Cord Injury
This study is testing whether a new non-invasive treatment that stimulates a nerve in the ear can help reduce inflammation and improve depression in people with spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT06493071 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on inflammation and depression in individuals with spinal cord injury (SCI). By applying an electrode to the skin of the ear, taVNS aims to stimulate the vagus nerve non-invasively, potentially reducing inflammation and improving depressive symptoms. The study will assess the efficacy of this treatment approach, as well as its impact on autonomic function measured through heart rate variability. Previous research has shown promise for taVNS in other populations, but its effects on those with SCI have not yet been explored.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with spinal cord injuries and mild to moderately severe depression.
Not a fit: Patients with severe depression, suicidal ideation, or certain medical conditions such as cardiovascular disease or epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a low-burden, non-invasive option for managing inflammation and depression in patients with spinal cord injuries.
How similar studies have performed: Other studies have shown success with vagus nerve stimulation in different populations, indicating potential for similar benefits in individuals with spinal cord injury.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
London, Ontario
- Parkwood Institute, St Joseph's Health Care London — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: David J Allison, PhD. — London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Study coordinator: David J Allison, PhD.
- Email: David.Allison@sjhc.london.on.ca
- Phone: 519 646 6100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.