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Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Sponsor: University of Calgary
Summary
Approximately 50% of people with chronic whiplash-associated disorders (WAD) continue to report the presence of symptoms 12 months post-injury. These symptoms include high levels of pain and disability as well as psychological symptoms such as post-traumatic stress. The nervous system may also be affected, specifically the autonomic nervous system which is responsible for regulating heart rate and blood pressure. An important part of the autonomic system is the vagus nerve, which helps regulate pain and stress responses. Treatment of this nerve via transauricular vagal nerve stimulation (taVNS) has been shown to improve health outcomes in many pain conditions such as chronic low back pain and postural tachycardia syndrome. TaVNS works by sending mild electrical pulses through the ear. This project aims to explore whether or not taVNS can help people with chronic whiplash-associated disorders (WAD) feel better. The first goal is to evaluate the safety and feasibility of taVNS. The investigators are interested in learning how many people with chronic WAD participate in the study and how many complete the full treatment, as well as ensuring that the treatment does not cause any serious side effects. An additional goal is to evaluate the effects of taVNS on neck pain intensity and associated disability, pain sensitivity, heart rate variability, blood pressure, quality of life, post-traumatic stress, stress, anxiety, and depression as measured by questionnaires and physical assessments, as compared to those assigned to the sham treatment.
Official title: The Safety and Feasibility of Transauricular Vagus Nerve Stimulation Therapy in Chronic Whiplash-Associated Disorders: A Randomized Pilot Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-07-01
Completion Date
2026-09-01
Last Updated
2025-07-08
Healthy Volunteers
No
Conditions
Interventions
Transauricular Vagal Nerve Stimulation
Transauricular VNS will be administered using the Parasym aVNT (auricular vagal neuromodulation therapy) Device (Nurosym, London, UK). The Parasym aVNT Device delivers non-invasive neuromodulation targeting the auricular branch of the vagus nerve via the tragus of the outer ear. All participants will receive four weeks of twice daily (morning and evening) 45-minute sessions of taVNS (frequency ≥ 25Hz; pulse width =250µs (Fig). The safety and tolerability of taVNS has been demonstrated in seven studies with a total of 205 (116 active, 121 sham) cardiovascular patients. Stimulation protocols ranged from 43 min to 8 hrs daily, for 1 day to 6 months. There were no device-related serious adverse events. Three patients (1.5%) experienced minor adverse events, i.e., dermal paresthesias (light tingling at the ear). No differences in tolerability were observed between active and sham taVNS \[21\].
Locations (1)
Vivo Cura Health
Calgary, Alberta, Canada