Recruiting

Neuromodulation

Sponsor:

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

Code:

NCT05730049

Conditions

Spinal Cord Injuries

Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Transcutaneous auricular vagus nerve stimulation

Study Details

Brief summary:

The goal of this single-blinded randomized, controlled trial is to assess the impact of 1-hour of active transcutaneous auricular vagus nerve stimulation (taVNS) vs sham taVNS on serum biomarkers of the inflammatory reflex and inflammation in individuals with spinal cord injury.

The main question it aims to answer is: whether taVNS is a safe and effective anti-inflammatory intervention for individuals with SCI. Participants will perform a single 1-hour bout of the respective taVNS treatment with blood draws prior to treatment, immediately following treatment, and 24 hours following treatment. Changes in biomarkers between the active and sham taVNS conditions will be compared.

Conditions

Spinal Cord Injuries

Inflammation

Study ID

NCT05730049

Start date

Jan 1, 2024

Status verified date

Apr, 2024

Completion date

Aug 31, 2024

Anticipated

Primary completion date

Aug 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Any level of severity of spinal cord injury
  • 18 years of age or older

Exclusion Criteria:

  • pregnant or attempting to become pregnant
  • people with active implants (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker)
  • people with cerebral shunts

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active taVNS

Stimulation will target the auricular branch of the vagus nerve by applying stimulation to the cymba conchae region of the ear 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 as performed in a previous protocol in stroke patients. Stimulation will be applied for a duration of 1 hour.

sham comparator: Sham taVNS

The control group will receive the same stimulation parameters but will have the earpiece placed in the sham position such that stimulation is applied to the earlobe and does not activate the vagus nerve.

Interventions

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 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(3). Pulse width will be set at 100μs and frequency will be set at 25Hz as performed in a previous protocol in stroke patients(3). The control group will receive the same stimulation parameters but will have the earpiece placed in the sham position such that stimulation is applied to the earlobe and does not activate the vagus nerve(4).

Primary outcome measure

  • Change in Serum Biomarkers Immediately Following Intervention [ Time Frame: Baseline - Immediately Following Intervention ]
  • Change in Serum Biomarkers 24-hours Following Intervention [ Time Frame: Baseline - 24-hour Post Intervention ]

Central Contacts and Locations

Central contacts

David J Allison, PhD.

519 646 6100David.Allison@sjhc.london.on.ca

Alexandria Roa Agudelo

519 646 6100Alexandria.RoaAgudelo@sjhc.london.on.ca

Locations

Parkwood Institute, St Joseph's Health Care London

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

David J Allison, PhD

2896680656David.Allison@sjhc.london.on.ca

More Information

Sponsor

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

Last update posted

Apr 29, 2024

Last verified

Apr, 2024

Keywords

  • Vagus Nerve Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-04-29.