Status:
RECRUITING
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Inflammation and Depression Following SCI
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions:
Spinal Cord Injury
Depression
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Depression and chronic inflammation are highly prevalent following SCI Inflammation plays an increasingly appreciated role in the pathology of depression. One key mechanism is the ability to dysregula...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06493071
Start Date
January 27 2025
End Date
August 30 2026
Last Update
February 7 2025
Active Locations (1)
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1
Parkwood Institute, St Joseph's Health Care London
London, Ontario, Canada, N6C 0A7