Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Inflammation and Depression Following SCI
Recruiting · NCT06493071 · Interventional (participants receive a specific treatment) · Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- SCI of any level or severity
- 18 years of age or older
- scores suggesting mild - moderately severe depression on the PHQ-9 (5 - 19)
- stable dose of depression medications
Exclusion criteria
- Prone to autonomic dysreflexia
- Severe depression as assessed by PHQ-9 (≥20)
- Suicidal ideation
- presence of cardiovascular disease
- pacemaker or other implanted electrical device (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker)
- people with cerebral shunts
- people with epilepsy
- people who pregnant or attempting to become pregnant.
Where it is running
1 location listed.
- Parkwood Institute, St Joseph's Health Care London - London, Ontario, Canada