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

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ClinicalTrials.gov Identifier: NCT04130893
Recruitment Status : Recruiting
First Posted : October 18, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Aix Marseille Université
Information provided by (Responsible Party):
Hôpital Européen Marseille

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.


Condition or disease Intervention/treatment Phase
Vasoconstriction Disorder of Extremities Behavioral: stimulation of G13 then G15 Behavioral: stimulation of G15 then G13 Not Applicable

Detailed Description:

Main objective: to measure the physiological impact of two auricular stimuli on the same innervation territory but with opposite actions according to traditional therapies.

An identical physiological response on both stimulation points would be an argument against the topographical precision adopted by traditional therapies; conversely, a different physiological response would suggest the existence of a somatotopy nestled in the same innervation territory.

Secondary objectives:

  • Determine, by sinus variability analysis, the intensity of the sympathetic and parasympathetic cardiac response of mechanical stimulation of the ear concha.
  • Determine the existence of a blockage of the sympathetic reaction on cutaneous vasoconstriction after mechanical stimulation of the ear concha.
  • Measure the relationship between sinus variability and paradoxical skin vasodilation after exposure to cold, as considered in the protocol.

To explore the justification for the topographical precision adopted by traditional therapies, we designed an experiment that consists of studying the autonomous, sympathetic and parasympathetic response to two stimuli performed over two different times.

The sympathetic stimulation will be done by immersing the right hand up to the wrist in a tub of cold water maintained at 5°C Mechanical parasympathetic stimulation will be performed on the ear in two different locations, by placing an adapted needle through an introducer to respect a standardized insertion depth.

The autonomous response will be measured by sinus variability, which responds to a double innervation, sympathetic and parasympathetic, and by the capillary skin response, which responds only to a sympathetic innervation.

The capillary skin response is measured by the amplitude and latency of the paradoxical vasodilation reflex following thermal stimulation, in this case the immersion of a limb's tip in cold water.

The study will consist of 3 sessions, as shown in the figure below. This is a prospective crossover study.

During the first session, the inclusion and non-inclusion criteria will be checked, then a water immersion test will be carried out to ensure the good tolerance of this test and then determine the basic values.

In the absence of acclimatization, the paradoxical vasodilation reflex is highly reproducible. During the second and third sessions, a mechanical stimulation will be done to the ear during the skin immersion test.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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.

Masking: None (Open Label)
Primary Purpose: Other
Official Title: Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)
Actual Study Start Date : January 17, 2019
Estimated Primary Completion Date : January 18, 2020
Estimated Study Completion Date : January 20, 2021

Arm Intervention/treatment
Experimental: A stimulation of G13 then G15
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
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.

Experimental: B: stimulation of G15 then G13
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
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.




Primary Outcome Measures :
  1. Skin temperature changes [ Time Frame: 20 minutes ]
    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


Secondary Outcome Measures :
  1. Pain reported by the participant [ Time Frame: 20 minutes ]
    Measured by visual analogue scale; this scale ranges from 0 to 10; 0 being no pain, 10 being excruciating pain.


Other Outcome Measures:
  1. Sinus variability [ Time Frame: 20 minutes ]
    measured by cardiofrequency meter(ACTIWAVE ®)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04130893


Contacts
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Contact: Emmanuel SAGUI, MD 0671286865 dr.emmanuel.sagui@gmx.fr
Contact: Wahiba BIDAUT, MSc 0685098699 wahibag@hotmail.com

Locations
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France
Hôpital Européen Marseille Recruiting
Marseille, Paca, France, 13003
Contact: Ghania HARZI, CRA    (33)4 13 42 77 82    g.harzi@hopital-europeen.fr   
Principal Investigator: Emmanuel SAGUI, MD         
Sub-Investigator: Laurent GRELOT, PhD         
Sponsors and Collaborators
Hôpital Européen Marseille
Aix Marseille Université
Investigators
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Principal Investigator: Emmanuel SAGUI, MD Hôpital Européen Marseille
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Responsible Party: Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT04130893    
Other Study ID Numbers: 18-36 AURIX
First Posted: October 18, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hôpital Européen Marseille:
ear acupuncture, auricular acupuncture