Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Inflammation and Depression Following SCI

NARecruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

January 27, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

August 30, 2026

Conditions
Spinal Cord InjuryDepression
Interventions
DEVICE

Active Transcutaneous Auricular Vagus Nerve Stimulation

Stimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear using the tVNS R device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA). Pulse width will be set at 100μs and frequency will be set at 25Hz. Parameters will be set for the duration of the intervention consisting of 4 hours of daily stimulation for a period of 30 days.

DEVICE

Sham Transcutaneous Auricular Vagus Nerve Stimulation

Stimulation will target the ear lobe using the NEMOS® taVNS device (taVNS Technologies, Erlangen, Germany). To achieve adequate stimulation while avoiding unpleasant or painful sensations, the stimulation intensity will be gradually increased in increments of 0.1mA until the subjective pain threshold is reached, and then reduced to a stimulus intensity just below the individuals pain threshold (expected range based on prior studies 1 - 3.2mA). Pulse width will be set at 100μs and frequency will be set at 25Hz. Participants will perform 4 hours of stimulation per day for a period of 30 days. Stimulation will be applied to the ear lobe in order to ensure participant feel the stimulation while avoiding activation of the vagus nerve.

Trial Locations (1)

N6C 0A7

RECRUITING

Parkwood Institute, St Joseph's Health Care London, London

All Listed Sponsors
lead

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER