Ultrasonic stimulation of the ear's vagus nerve in healthy adults
UltraSONIC Vagus Nerve Stimulation: Investigation U-VNS Effects on Physiological, Emotional and Cognitive Biomarkers
This will test whether placing a painless ultrasound device on the ear can stimulate the vagus nerve in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Nottingham Academic / other |
| Locations | 2 sites (Nottingham, Nottinghamshire and 1 other locations) |
| Trial ID | NCT07283913 on ClinicalTrials.gov |
What this trial studies
Researchers will deliver non-invasive focused ultrasound to the auricular branch of the vagus nerve in healthy volunteers to see if this activates parasympathetic responses. Participants attend multiple visits with requirements such as removing left-ear piercings and fasting beforehand, while investigators record physiological and metabolic signals. The approach aims to provide a non-electrical alternative to implanted or transcutaneous electrical VNS, reducing risks associated with surgery or skin electrodes. Measurements likely include heart rate, breathing or other autonomic markers and metabolic signals such as glucose to determine acute effects of the stimulation.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 or older who are not taking medications (except contraceptives), have no major neurological, psychiatric, cardiac, or metabolic disorders, and can follow study requirements like fasting and removing left-ear piercings.
Not a fit: People with diabetes, significant heart conditions or arrhythmias, high blood pressure, recent use of nervous-system–active drugs, or those seeking treatment for an existing medical condition are unlikely to benefit from participating in this healthy-volunteer protocol.
Why it matters
Potential benefit: If successful, this could offer a non-invasive way to modulate the vagus nerve that might lead to safer, easier treatments for conditions currently treated with electrical or implanted VNS.
How similar studies have performed: Electrical and transcutaneous auricular VNS have shown therapeutic effects for epilepsy and some neuropsychiatric conditions, but ultrasonic auricular VNS in humans is novel with limited prior human data and mixed results for some indications.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Participant is willing and able to give informed consent for participation in the study * Not currently taking any medications (except the contraceptive pill) * Aged 18 or over * Good general health * Able and willing to remove any piercings in the left ear * Able to abstain from exercise and fast from food for 12 hours before the second and third visit Exclusion Criteria * Current or past diagnosis of a major neurological, neurosurgical, or psychiatric disorder (including self-reported depression) * Inability to complete informed consent process * Personal history of cardiac arrhythmia * Diabetes * High blood pressure (\>140 mmHg systolic and/or \>90 mmHg diastolic) * Other significant medical condition (including cardiological disorders; specific details to be reviewed by the CI prior to inclusion) * Use of medication or recreational drugs that affect the nervous system in the past 3 months * Medication intake (such as beta-blockers, glucocorticoids, antidepressants, anti-inflammatory drugs) in the last 7 days - contraceptive medication in women is allowed * Currently pregnant or breastfeeding * Allergy to aquasonic gel or any of its components (propylene glycol, glycerin, isothiazolinones) * Participation in a research study in the last 3 months involving invasive procedures or an inconvenience allowance (required for all UoN FMHS UREC-approved studies) * BMI \< 18 kg/m² or \> 30 kg/m² * Excessive consumption of alcohol (\>2 alcoholic beverages/day) or tobacco (\>5 cigarettes/day) * Previous experience with stress tests * Known infection in the last 8 weeks
Where this trial is running
Nottingham, Nottinghamshire and 1 other locations
- Neuromodulation Lab, Medical School, Queen's Medical Centre — Nottingham, Nottinghamshire, United Kingdom (Recruiting)
- University of Nottingham — Nottingham, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Marcus Kaiser, Professor — University of Nottingham
- Study coordinator: Alicia Falcon-Caro, PhD
- Email: Alicia.falconcaro@nottingham.ac.uk
- Phone: +44 7502043643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.