Publication Date: October 5, 2025
A new clinical trial has been announced to investigate the combined use of virtual reality (VR) and trans-auricular vagus nerve stimulation (VNS) as potential interventions for patients with anxiety and depression stemming from chronic shoulder pain. The study, sponsored by the East Kent Hospitals University NHS Foundation Trust, has not yet begun recruiting participants as of this announcement.
What is the purpose of this trial?
The trial aims to evaluate the efficacy of integrating VR and VNS technologies to alleviate symptoms of anxiety and depression in individuals suffering from chronic shoulder pain. Chronic pain often coexists with psychological conditions, and this study focuses on exploring whether these devices can deliver combined therapeutic benefits.
Virtual reality technology provides an immersive experience, which can reduce pain perception by distracting patients or fostering stress reduction. Meanwhile, trans-auricular vagus nerve stimulation, a non-invasive stimulation of the vagus nerve via the ear, holds potential for modulating mood and treating anxiety and depression. By combining these two approaches, the research seeks to investigate their additive or synergistic effects on both mental health and chronic pain management.
Why does this combination matter?
Current treatment options for chronic pain-associated psychological conditions typically involve pharmacological therapies such as antidepressants or anxiolytics. However, these medications often come with side effects and are not universally effective. Alternative methods such as VR and VNS present non-pharmacological solutions that could improve patient outcomes without similar risks.
This trial is noteworthy within the medical device community given the growing interest in personalized and non-invasive treatment technologies. Devices like VR systems and auricular vagus nerve stimulators are showing potential for becoming cornerstones in future multidisciplinary approaches to chronic pain and mental health management.
Who might be eligible?
Although recruitment has not begun, patients diagnosed with chronic shoulder pain and conditions such as anxiety or depression may be prospective participants. Eligibility inclusion criteria and study recruitment processes will likely be disclosed closer to the trial’s official start date.
Regulatory teams tracking medical device innovations may also find this study useful as a benchmark for showcasing the safety and performance of innovative combinatory treatments in clinical applications.
FAQs
- 1. What is vagus nerve stimulation?
- Vagus nerve stimulation is a technique that involves electrical stimulation of the vagus nerve, known to influence various physiological and psychological processes including mood regulation.
- 2. How does virtual reality help with pain management?
- VR can create immersive environments that distract from pain, reduce stress, and promote relaxation. This method is increasingly used as a complementary therapy in pain management.
- 3. When will the trial begin recruiting?
- The trial is currently in the “not yet recruiting” phase. Recruitment timelines will likely be announced by the sponsor organization.
Summary and next steps
This study offers an exciting opportunity to explore innovative, device-driven interventions for a complex and challenging patient population. Regulatory and clinical teams should monitor its progress to glean insights that could inform product development or treatment guidelines.
For stakeholders, understanding how these combined therapies perform may open the door to new therapeutic strategies that benefit patients with overlapping chronic pain and mental health issues.
Disclaimer
This article is meant for informational purposes only and does not constitute legal or clinical advice. Consult the appropriate regulatory or clinical experts for specific concerns.
Further reading
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07198737?term=medical+device