Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07055373

Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders

Led by University of Calgary · Updated on 2026-05-01

40

Participants Needed

1

Research Sites

66 weeks

Total Duration

On this page

Sponsors

U

University of Calgary

Lead Sponsor

V

Vivo Cura Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Symptom duration of 3 months or more and less than 10 years
  • Classified as WAD grade I, II, or III
  • Average neck pain intensity of 4 or higher out of 10
  • Neck Disability Index score greater than 28% (more than 14 out of 50)
Not Eligible

You will not qualify if you...

  • WAD grade IV injury (fracture, dislocation, or no neurological deficit)
  • Presence of concussion symptoms
  • Previous cervical vagotomy surgery
  • Diagnosis of severe bradycardia
  • Permanent implanted metallic or electronic device or jewelry near the ear tragus
  • Any active implanted medical device such as cochlear implants, cerebral shunts, or invasive vagus nerve stimulators
  • Open wounds, rashes, swelling, infection, inflammation, or cancerous lesions near the stimulation area
  • Use of medications affecting autonomic nervous system function, like Beta Blockers
  • Serious health conditions such as neurological disorders, inflammatory diseases, severe cardiovascular disease, metabolic disorders, visual impairments, serious spinal pathology, pregnancy, or prior spinal surgery
  • History of mental health conditions before motor vehicle collision, including bipolar disorder, schizophrenia, anxiety, PTSD, or severe depression
  • Inability to complete study questionnaires

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Vivo Cura Health

Calgary, Alberta, Canada, T2E 2P5

Actively Recruiting

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Research Team

J

Jennifer Laxshimalla

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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