Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x) (NCT04130893) | Clinical Trial Compass
TerminatedNot Applicable
Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)
Stopped: Investigator's decision
France10 participantsStarted 2019-01-17
Plain-language summary
While invasive vagal stimulation has proven its therapeutic effectiveness over the past 20 years, particularly in the treatment of epilepsy or depression, its implementation is hampered by the high cost, high technicality and sometimes significant side effects. Non-invasive vagal stimulation, most often electric, is a less expensive therapeutic alternative and easier to implement, although the level of evidence is lower than that of invasive stimulation.
Some so-called traditional therapies, such as acupuncture, also stimulate certain parts of the ear by mechanical means, most often by puncturing the ear or the concha. In these traditional therapies, more than one hundred stimulation points have been described, each precisely positioned according to an empirical topography.
However, electrical non-invasive stimulation recognizes only three areas of interest on the ear, which are the areas of sensitive innervation, namely the afferences of the vagus nerve in the concha, which is the only one used in practice, the large occipital nerve on the lobe and part of the helix, and the auriculotemporal nerve on the rest of the auricular flag.
In this study, we would like to explore the justification for the topographic precision, adopted by traditional therapies, for non-invasive vagal stimulation on the concha.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy volunteers, male and female, aged 18 to 60 years
* BMI (Body mass index) \<=30
* Not participating in another clinical study with an investigational product
Exclusion Criteria:
* Drug treatment for cardiological, neurological or anticoagulant purposes
* History of diabetes, known neuropathy, high blood pressure, heart rhythm disorders, syncope or palpitation
* Known cryoglobulinemia
* Subject with Raynaud's syndrome
* Intra-auricular device of the piercing type,
* Psychoactive substance use, excessive alcohol consumption (\>2 units per day chronically or \>6 units per day recreationally) and tobacco (\>5 cigarettes per day)
* Subject unable to read French
* Subject covered by Articles L1121-5 to 1121-8 of the Public Health Code, namely:
* Pregnant, postpartum and breastfeeding women
* Persons deprived of their liberty by a judicial or administrative decision
* Persons undergoing psychiatric care under Articles L3112-1 and L3113-1 who are not covered by the provisions of Article L1121-8
* Minors
* Persons of full age who are subject to a legal protection measure or who are unable to express their consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.