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Search / Trial NCT07055373

Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders

Launched by UNIVERSITY OF CALGARY · Jun 27, 2025

Trial Information

Current as of November 05, 2025

Not yet recruiting

Keywords

Whiplash Associated Disorder (Wad) Vagus Nerve Stimulation Parasympathetic Nervous System Sympathetic Nervous System Post Traumatic Stress Central Sensitization Heart Rate Variability Pupillometry

ClinConnect Summary

This clinical trial is studying a new treatment called transauricular vagus nerve stimulation (taVNS) to help people who have long-lasting neck pain and other symptoms after a whiplash injury, which often happens during car accidents. This treatment uses gentle electrical pulses sent through the ear to stimulate a nerve called the vagus nerve, which plays a role in controlling pain and stress. The trial aims to see if this treatment is safe, if people are willing to complete it, and whether it can reduce neck pain, improve daily function, and help with symptoms like stress, anxiety, and sleep problems.

People who might be eligible for this study are adults who have had neck pain from whiplash for at least three months but less than ten years, with moderate to severe pain and some difficulty moving their neck. The study excludes those with more serious neck injuries, certain medical conditions, or implanted devices near the ear. Participants will receive either the real treatment or a sham (placebo) version, and researchers will track their pain, physical function, heart rate, blood pressure, and overall well-being through questionnaires and physical tests. This study is not yet recruiting, but it offers hope for new ways to manage chronic whiplash symptoms.

Gender

ALL

Eligibility criteria

  • 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.

About University Of Calgary

The University of Calgary is a leading research institution dedicated to advancing health and science through innovative clinical trials. With a strong emphasis on multidisciplinary collaboration, the university's clinical research initiatives aim to address pressing health challenges and improve patient outcomes. The institution fosters a robust environment for academic inquiry, leveraging state-of-the-art facilities and a diverse network of experts in various fields. Committed to ethical research practices and community engagement, the University of Calgary strives to translate scientific discoveries into tangible benefits for society.

Locations

Calgary, Alberta, Canada

Patients applied

0 patients applied

Trial Officials

Ashley Smith

Principal Investigator

University of Calgary

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported