Recruiting

taVNS

Sponsor:

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

Code:

NCT06493071

Conditions

Spinal Cord Injury

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Active Transcutaneous Auricular Vagus Nerve Stimulation

Sham Transcutaneous Auricular Vagus Nerve Stimulation

Study Details

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 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.

Conditions

Spinal Cord Injury

Depression

Study ID

NCT06493071

Start date

Jan 27, 2025

Status verified date

Jul, 2024

Completion date

Aug 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. SCI of any level or severity
2. 18 years of age or older
3. scores suggesting mild - moderately severe depression on the PHQ-9 (5 - 19)
4. stable dose of depression medications

Exclusion criteria:

1. Prone to autonomic dysreflexia
2. Severe depression as assessed by PHQ-9 (≥20)
3. Suicidal ideation
4. presence of cardiovascular disease
5. pacemaker or other implanted electrical device (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker)
6. people with cerebral shunts
7. people with epilepsy
8. people who pregnant or attempting to become pregnant.

Study Design

Enrollment

44 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).

sham comparator: Sham taVNS

Stimulation will target the ear lobe using the NEMOS® taVNS device (taVNS Technologies, Erlangen, Germany). Stimulation will be applied to the ear lobe in order to ensure participant feel the stimulation while avoiding activation of the vagus nerve.

Interventions

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.

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.

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events During Intervention [ Time Frame: 30 days ]
  • Change in Root Mean Square of Successive Differences (RMSSD) [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

Parkwood Institute, St Joseph's Health Care London

Recruiting

London, Ontario, Canada, N6C 0A7

Contacts

More Information

Sponsor

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

Last update posted

Feb 7, 2025

Last verified

Jul, 2024

Keywords

  • Vagus Nerve Stimulation
  • Inflammation
  • Kynurenine
  • Spinal Cord Injury
  • Depression

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 2025-02-07.