Transcutaneous Auricular Vagus Nerve Stimulation as a Treatment for Neuropathic Pain Following Spinal Cord Injury

Sponsor
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study ID
NCT07588711
Status
Not Yet Recruiting

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Conditions

  • Neuropathic Pain
  • Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Active Transcutaneous Auricular Vagus Nerve Stimulation — DEVICE
    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 (milliamps) 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 (microseconds) and frequency will be set at 25Hz (Hertz). Parameters will be set for the duration of the intervention consisting of 4 hours of daily stimulation for a period of 30 days.
  • Sham Transcutaneous Auricular Vagus Nerve Stimulation — DEVICE
    Stimulation will target the ear lobe 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. 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.

Study Details

This pilot randomized, double-blind, sham-controlled clinical investigation will evaluate the feasibility and safety of a 30-day home-based transcutaneous auricular vagus nerve stimulation (taVNS) intervention in adults with spinal cord injury (SCI) and neuropathic pain. Participants will be randomized to receive either active taVNS targeting the auricular branch of the vagus nerve or sham taVNS delivered to the earlobe. Primary outcomes include feasibility, safety, adherence, acceptability, and blinding success. Exploratory outcomes include changes in neuropathic pain, systemic inflammatory biomarkers, vagal tone assessed via heart rate variability, and quality of life.

Key Dates

First listed
May 15, 2026
Start date
Oct 1, 2026
Status verified
Apr 2026
Primary completion
May 1, 2028
Completion
Aug 30, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active taVNS
    Participants receive active transcutaneous auricular vagus nerve stimulation delivered via the cymba conchae of the left ear using the using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 30 days.
  • Sham Comparator: Sham taVNS
    Stimulation will target the ear lobe using the tVNS R device (taVNS Technologies, Erlangen, Germany) for 4 hours per day for 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.

Primary Outcome Measure

Recruitment Rate and Time to Recruit Target Sample Size [ Time Frame: Up to 20 months ]

Central Contacts

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