Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)

NCT04130893 | Terminated

• 1 other identifier: 18-36
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vasoconstriction Disorder of Extremities

Keywords

ear acupuncture, auricular acupuncture

Outcome Measures

Primary Outcomes (1)

• Skin temperature changes

  measured by thermocouples placed on the following fingers: thumb, middle finger and ear of the right hand. The values and times of the minimum and maximum temperatures (latency and amplitude of (CIVD) Cold-Induced VasoDilatation waves) are measured

  20 minutes

Secondary Outcomes (1)

• Pain reported by the participant

  20 minutes

Other Outcomes (1)

• Sinus variability

  20 minutes

Study Arms (2)

A stimulation of G13 then G15

EXPERIMENTAL

The first session is similar between the two arms: Cold water hand immersion only At the Second session: Cold water hand immersion + G13 auricular stimulation At the Third session: Cold water hand immersion + G15 auricular stimulation

Behavioral: stimulation of G13 then G15

B: stimulation of G15 then G13

EXPERIMENTAL

The first session is similar between the two arms: Cold water hand immersion only At the Second session: Cold water hand immersion + G15 auricular stimulation At the Third session: Cold water hand immersion + G13 auricular stimulation

Behavioral: stimulation of G15 then G13

Interventions

stimulation of G13 then G15 BEHAVIORAL

Study participant randomized into arm A will undergo a stimulation of point G13 at session N°2, then stimulation of point G15 at session N°3.

A stimulation of G13 then G15

stimulation of G15 then G13 BEHAVIORAL

Study participant randomized into arm B will undergo a stimulation of point G15 at session N°2, then stimulation of point G13 at session N°3.

B: stimulation of G15 then G13

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hôpital Européen Marseille: lead
• Aix Marseille Université: collaborator

Study Sites (1)

Hôpital Européen Marseille

Marseille, PACA, 13003, France

Location

Related Publications (1)

• Sagui E, Claverie D, Bidaut W, Grelot L. Heart rate variability and cold-induced vascular dilation after stimulation of two different areas of the ear: a prospective, single-blinded, randomized crossover study. BMC Complement Med Ther. 2024 Feb 13;24(1):83. doi: 10.1186/s12906-024-04392-7.

  PMID: 38350937 DERIVED

Study Officials

• Emmanuel SAGUI, MD

  Hôpital Européen Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will consist of 3 sessions, It is a prospective crossover study. During the first session, the inclusion and non-inclusion criteria will be checked, then the cold water hand immersion test will be carried out to ensure the good tolerance of this test and then determine the basic values. During the second and third sessions, Two different auricular stimuli will be done to the ear during the hand immersion test.

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 18, 2019
• Study Start: January 17, 2019
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: September 25, 2025

Record last verified: 2022-01

Locations

FR (1)