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
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|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|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)|
|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|
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.
- 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
- 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.
- Sinus variability [ Time Frame: 20 minutes ]measured by cardiofrequency meter(ACTIWAVE ®)
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
|Contact: Emmanuel SAGUI, MDemail@example.com|
|Contact: Wahiba BIDAUT, MScfirstname.lastname@example.org|
|Hôpital Européen Marseille||Recruiting|
|Marseille, Paca, France, 13003|
|Contact: Ghania HARZI, CRA (33)4 13 42 77 82 email@example.com|
|Principal Investigator: Emmanuel SAGUI, MD|
|Sub-Investigator: Laurent GRELOT, PhD|
|Principal Investigator:||Emmanuel SAGUI, MD||Hôpital Européen Marseille|