Vagus Nerve Stimulation for Whiplash

Overseen By Jennifer Laxshimalla

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Calgary

Must not be taking: Beta blockers

Disqualifiers: Neurological, Inflammatory, Cardiovascular, Metabolic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called transauricular vagal nerve stimulation (taVNS) for individuals with chronic whiplash-associated disorders (WAD). The goal is to determine if this treatment, which uses mild electrical pulses through the ear, can reduce neck pain and improve symptoms like stress and anxiety. Researchers aim to assess the safety and practicality of taVNS by comparing it to a sham treatment to evaluate its effectiveness. Suitable candidates for this trial have experienced neck pain for at least three months, have movement issues or tenderness, and consider their pain significant. As an unphased trial, this study provides a unique opportunity to investigate a novel treatment option for chronic neck pain.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that affect the autonomic nervous system, like Beta Blockers. If you're on such medications, you may need to stop them to participate.

What prior data suggests that transauricular vagal nerve stimulation is safe for people with chronic whiplash-associated disorders?

Research has shown that transauricular vagal nerve stimulation (taVNS) is generally safe and well-tolerated. Studies have found that both healthy individuals and those with conditions like stroke experience few side effects, with no serious issues reported. This treatment sends gentle electrical pulses through the ear to stimulate the vagus nerve, aiding in pain and stress management. Overall, taVNS appears promising for improving health in various pain conditions without major safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for whiplash focus on pain relief through medications like NSAIDs or physical therapy to improve mobility. However, transauricular vagal nerve stimulation (taVNS) stands out because it targets the autonomic nervous system by delivering mild electrical pulses to the vagus nerve through the ear. This unique approach may help reduce pain and improve autonomic function, potentially offering relief without the side effects of medications. Researchers are excited because taVNS could provide a non-invasive, drug-free option that addresses both pain and nervous system regulation, which current treatments don't fully address.

What evidence suggests that transauricular vagal nerve stimulation is effective for chronic whiplash-associated disorders?

Research has shown that transauricular vagal nerve stimulation (taVNS) can help with various pain conditions. In previous studies, taVNS improved symptoms for individuals with chronic low back pain and postural tachycardia syndrome. This treatment sends gentle electrical pulses through the ear, which can help manage pain and stress. In this trial, participants will receive either active taVNS or a sham version. Early evidence suggests taVNS might be safe and effective for individuals with chronic whiplash-associated disorders (WAD) because it targets the vagus nerve, which plays a key role in controlling pain and stress. Overall, these findings offer hope that taVNS could relieve symptoms for those suffering from chronic WAD. ^{1 3 6 7 8}

Who Is on the Research Team?

Ashley Smith

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for individuals with chronic whiplash-associated disorders (WAD) who still have symptoms like pain, disability, and psychological stress a year after their injury. Participants should be interested in trying a non-drug treatment involving mild electrical pulses through the ear to potentially improve their condition.

Inclusion Criteria

Neck Disability Index score > 28% (14/50)

My average pain level is 4 or higher on a scale of 10.

My symptoms have been present for more than 3 months but less than 10 years.

Exclusion Criteria

I have a type IV whiplash injury without nerve damage or bone issues.

I have had mental health conditions like bipolar disorder, schizophrenia, anxiety, PTSD, or severe depression before the MVC.

I am experiencing symptoms of a concussion.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transauricular vagal nerve stimulation (taVNS) twice daily for 4 weeks

4 weeks

Daily self-administered sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-ups at 4-6 weeks and 12 weeks post-treatment

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Transauricular Vagal Nerve Stimulation

Trial Overview The study tests transauricular vagal nerve stimulation (taVNS), which targets the vagus nerve to alleviate pain and stress responses. The goal is to assess its safety, feasibility, and effectiveness on neck pain intensity, disability, heart rate variability, blood pressure, quality of life, and psychological symptoms compared to a sham treatment.

How Is the Trial Designed?

Group I: Active Transauricular Vagal Nerve Stimulation Active Control 1 Intervention

Upon enrolment, participants randomized into the active treatment arm will be asked to complete a series of questionnaires seeking information on physical measurements (height, weight, \& BMI), accident history, current symptoms, treatments received to date, and quality of life. Physical assessments will be performed to assess autonomic function and pain sensitivity including pupillary light reflex, heart rate variability, temporal summation, pressure pain thresholds, and conditioned pain modulation. Transauricular vagal nerve stimulation (taVNS) will be delivered a via a device that sends mild electrical pulses through the tragus of the outer ear. Participants will receive instructions device use in order to complete four weeks of twice daily (morning and evening) 45 minute sessions of taVNS. Follow ups will be completed immediately post intervention and at 4-6 weeks and 12 weeks 1 month post active taVNS. Participants will be asked to track device usage and report any adverse events.

Group II: Sham Transauricular Vagal Nerve Stimulation Placebo Group 1 Intervention

Participants assigned to the sham treatment arm will be asked to complete all the same questionnaires and physical assessments as those assigned to the active treatment arm. They will also be provided with a taVNS device and instructions on use. The device will be programed by the research team to reduce the output to '0' and thus those assigned to the sham group will not actually be receiving any active treatment. Participants will not be able to distinguish if any treatment is being received.

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials

827

Recruited

902,000+

Vivo Cura Health

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07055373?viewType=Table&rank=6

Transauricular Vagus Nerve Stimulation for Chronic ... Transauricular VNS (taVNS) has been shown to improve health outcomes in many dysautonomic conditions and pain, such as chronic low back pain and postural ...

2. withpower.com withpower.com/trial/phase-whiplash-associated-disorder-wad-6-2025-2d668

Vagus Nerve Stimulation for Whiplash · Info for Participants 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 ...

3. research.ucalgary.ca research.ucalgary.ca/participate/safety-and-feasibility-transauricular-vagus-nerve-stimulation-therapy-chronic-whiplash-associated-reb25-0529

The Safety and Feasibility of Transauricular Vagus Nerve ... The objective of this study is to evaluate the safety and feasability of transauricular vagus nerve stimulation for patients with chronic whiplash ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10017768/

Transauricular vagus nerve stimulation for patients with ... These preliminary data provide early evidence that tVNS may be an effective and safe approach for promoting the recovery of consciousness, especially in ...

5. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1274432/pdf

Current status and prospect of transcutaneous auricular ... In this paper, we review the literature on taVNS and DOC to better understand the current status and development prospect of taVNS treament as a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10618368/

Transcutaneous auricular vagus nerve stimulation in the ... This review provides an in-depth exploration of the mechanisms and applications of transcutaneous auricular vagus nerve stimulation (taVNS) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10752952/

a sham-controlled randomized double-blind clinical trial - PMC The findings of this study suggest that taVNS may serve as a potentially effective and safe intervention for facilitating the restoration of ...

8. researchgate.net researchgate.net/publication/327180319_Safety_and_Tolerability_of_Transcutaneous_Vagus_Nerve_Stimulation_in_humans_a_systematic_review

Safety and Tolerability of Transcutaneous Vagus Nerve ... Researchers have reported a low rate of adverse events and no serious events when applying taVNS to healthy individuals as well as patients with stroke, ...