Ear-based vagus nerve stimulation for chronic whiplash-associated disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional project uses transauricular vagus nerve stimulation (taVNS) delivered through the ear to target autonomic nervous system imbalance thought to contribute to chronic whiplash-associated disorder (WAD). The initial focus is on safety and feasibility, with participants meeting criteria for chronic WAD (symptoms 3 months to under 10 years, average pain ≥4/10, and Neck Disability Index >28%). Participants with implanted electronic devices, severe bradycardia, recent concussion, or open ear wounds are excluded for safety. Outcomes include autonomic measures, pain and disability scores, and monitoring for adverse effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Symptom duration ≥3 months and \<10 years; and
2. Classifiable as WAD grade I (neck pain without physical impairments) or II (neck pain \& impairment such as movement loss and/or tenderness) or III (neck pain \& neurological deficit evident on physical exam);
3. Average pain intensity (over one week) ≥ 4/10;
4. Neck Disability Index score \> 28% (14/50).

Exclusion Criteria:

1. WAD IV injury (no neurological deficit, fracture, or dislocation);
2. Concussion symptoms;
3. Patients who have undergone cervical vagotomy;
4. Patients diagnosed with severe bradycardia;
5. Patients with a permanent implanted metallic or electronic device or jewellery at close proximity to the ear tragus;
6. Patients with any active implanted device (including electronic and/or medical devices) e.g. cochlear implant, cerebral shunts, invasive vagus nerve stimulators, or non-active but potentially interacting with the nervous system (e.g., metal implants);
7. Open wounds or rashes, swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins); or cancerous lesions in the area of stimulation
8. Using medications associated with ANS function such as Beta Blockers;
9. Adverse general health factors such as presence of a neurological disorder (e.g., multiple sclerosis), inflammatory condition (e.g., rheumatoid arthritis), cardiovascular disorder (known severe coronary disease or recent myocardial infarction (within 5 years)); metabolic disorder (e.g., diabetes), visual deficit or disease process (e.g. cataracts, double or blurred vision), known or suspected serious spinal pathology (e.g. metastatic disease of the spine), pregnancy, or previous spinal surgery or recurrent treatment for spinal disorders;
10. History of any mental health conditions prior to the MVC, such as bipolar disorder, schizophrenia, anxiety, PTSD or severe depression;
11. People who are unable to complete the questionnaires.

Where it's running

• Vivo Cura Health
  Calgary, Alberta, Canada Recruiting

Study contacts

• Principal investigator: Ashley Smith — University of Calgary
• Study coordinator: Jennifer Laxshimalla
• Email: jennifer.laxshimalla@vivocura.ca
• Phone: 403-265-3838

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.