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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Alicia Falcon-Caro, PhD
+44 7502043643
Alicia.falconcaro@nottingham.ac.uk
Stefanos A Kontogouris, MSc
+44 7826221912
stefanos.kontogouris@nottingham.ac.uk
Healthy Participants
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The Vagus nerve, one of 12 cranial nerves that connect the brain to the human body, controls specific involuntary functions such as breathing, heart rate, the digestive system and the immune system, and it is crucial to unlocking the relaxation response (parasympathetic nervous system).
Vagus nerve stimulation (VNS) can be invasive or non-invasive, and both methods have been trialled in research studies. Some non-invasive VNS involves the use of a device which is placed on the skin, to send electrical impulses to the Vagus nerve. The device sends electrical impulses to some areas of the brain which changes brain activity and helps in treating certain disorders. Invasive methods utilise a surgically implanted Vagus nerve stimulator on the left Vagus nerve in the neck area.
VNS is used in treatment of epilepsy and studies has shown to have a therapeutic effect on treatment resistant depression. Currently, research indicates that invasive VNS to treat anxiety yield mixed results, whilst other studies suggest that VNS with exposure-based therapies might enhance outcomes for anxiety patients.
Stimulating the Vagus nerve comes with serious technical challenges. Most importantly, electric currents follow the path of least resistance. When running through biological tissues, such as skin, cartilage or bone, it is difficult to aim for the part of the body that needs to be stimulated. This means it isn't always easy to tell whether the Vagus nerve is indeed being stimulated and how much of the current is reaching the Vagus nerve.
This problem can be overcome by ultrasound stimulation. Ultrasound stimulation employs high frequency sound waves to stimulate tissue. These soundwaves travel through the human body much more predictably than electric currents. As such, ultrasound stimulation of the Vagus nerve may be more effective than electrical stimulation. The ZenBud device is designed to apply ultrasound stimulation to part of the auricular branch of the Vagus nerve. Ultrasound stimulation allows for more targeted stimulation, increasing the chance of the stimulation reaching the Vagus nerve. The ZenBud device is safe for use in healthy adults and received CE marking.
Before testing the therapeutic effect of the Zenbud on patients with symptoms it is important to identify physiological, cognition or emotional changes in health volunteers. Identifying these changes could lead to identifying possible future therapeutic uses for ultrasound-VNS (U-VNS).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
"Colzato L, Beste C. A literature review on the neurophysiological underpinnings and cognitive effects of transcutaneous vagus nerve stimulation: challenges and future directions. J Neurophysiol. 2020 May 1;123(5):1739-1755. doi: 10.1152/jn.00057.2020. Epub 2020 Mar 25."; "32208895"; "Bartolomei F, Bonini F, Vidal E, Trebuchon A, Lagarde S, Lambert I, McGonigal A, Scavarda D, Carron R, Benar CG. How does vagal nerve stimulation (VNS) change EEG brain functional connectivity? Epilepsy Res. 2016 Oct;126:141-6. doi: 10.1016/j.eplepsyres.2016.06.008. Epub 2016 Jul 29."; "27497814"; "Johnson RL, Wilson CG. A review of vagus nerve stimulation as a therapeutic intervention. J Inflamm Res. 2018 May 16;11:203-213. doi: 10.2147/JIR.S163248. eCollection 2018."; "29844694"; "Liu RP, Fang JL, Rong PJ, Zhao Y, Meng H, Ben H, Li L, Huang ZX, Li X, Ma YG, Zhu B. Effects of electroacupuncture at auricular concha region on the depressive status of unpredictable chronic mild stress rat models. Evid Based Complement Alternat Med. 2013;2013:789674. doi: 10.1155/2013/789674. Epub 2013 Jan 29."; "23431349"; "Henry TR. Therapeutic mechanisms of vagus nerve stimulation. Neurology. 2002 Sep 24;59(6 Suppl 4):S3-14. doi: 10.1212/wnl.59.6_suppl_4.s3."; "12270962"; "Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr;236(4):588-611. doi: 10.1111/joa.13122. Epub 2019 Nov 19."; "31742681"; "Toffa DH, Touma L, El Meskine T, Bouthillier A, Nguyen DK. Learnings from 30 years of reported efficacy and safety of vagus nerve stimulation (VNS) for epilepsy treatment: A critical review. Seizure. 2020 Dec;83:104-123. doi: 10.1016/j.seizure.2020.09.027. Epub 2020 Oct 10."; "33120323"; "Breit S, Kupferberg A, Rogler G, Hasler G. Vagus Nerve as Modulator of the Brain-Gut Axis in Psychiatric and Inflammatory Disorders. Front Psychiatry. 2018 Mar 13;9:44. doi: 10.3389/fpsyt.2018.00044. eCollection 2018."; "29593576"; "Yuan H, Silberstein SD. Vagus Nerve and Vagus Nerve Stimulation, a Comprehensive Review: Part I. Headache. 2016 Jan;56(1):71-8. doi: 10.1111/head.12647. Epub 2015 Sep 14."; "26364692"; "Kohler I, Hacker J, Martin E. Reduction of Anxiety-Related Symptoms Using Low-Intensity Ultrasound Neuromodulation on the Auricular Branch of the Vagus Nerve: Preliminary Study. JMIR Neurotechnol. 2025 May 1;4:e69770. doi: 10.2196/69770. eCollection 2025."; "41341418"
You can take part if:
You may not be able to take part if:
This is in the inclusion criteria above
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Stefanos A Kontogouris, MSc
+44 7826221912
stefanos.kontogouris@nottingham.ac.uk
Alicia Falcon-Caro, PhD
+44 7502043643
Alicia.falconcaro@nottingham.ac.uk
The study is sponsored by University of Nottingham and is in collaboration with University of Cambridge.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
