Ultrasonic stimulation of the ear's vagus nerve in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.