Vasoconstriction Disorder of ExtremitiesAURIXNCT04130893
Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)
A study testing stimulation of G13 then G15 and stimulation of G15 then G13 in people with Vasoconstriction Disorder of Extremities, run by Hôpital Européen Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasoconstriction Disorder of Extremities
- What is being tested?
- stimulation of G13 then G15 and stimulation of G15 then G13
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2019to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Vasoconstriction Disorder of Extremities
- Being tested
- stimulation of G13 then G15, stimulation of G15 then G13
- Keywords
- ear acupuncture, auricular acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stimulation of G13 then G15Behavioural
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.
stimulation of G15 then G13Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: stimulation of G15 then G13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 minutes
Secondary outcomes (1)
Pain reported by the participant
Measured by visual analogue scale; this scale ranges from 0 to 10; 0 being no pain, 10 being excruciating pain.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start17 Jan 2019
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Why it stopped: Investigator's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vasoconstriction Disorder of ExtremitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Collaborators
- Aix Marseille Université
- Responsible party
- Sponsor
- Investigators
- Emmanuel SAGUI, MD, Principal investigator, Hôpital Européen Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130893
- Sponsor's protocol ID
- 18-36
- Acronym
- AURIX
- Status last verified
- Jan 2022
- First submitted
- 16 Oct 2019
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38350937
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)
- ClinicalTrials.gov ID
- NCT04130893
- Acronym / sponsor ID
- AURIX / 18-36
- Conditions
- Vasoconstriction Disorder of Extremities
- Keywords
- ear acupuncture, auricular acupuncture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator's decision
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Collaborators
- Aix Marseille Université
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 18 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| A stimulation of G13 then G15 | Experimental | Behavioral: stimulation of G13 then G15The 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 |
| B: stimulation of G15 then G13 | Experimental | Behavioral: stimulation of G15 then G13The 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stimulation of G13 then G15Study 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. | Behavioural | A stimulation of G13 then G15 |
| stimulation of G15 then G13Study 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. | Behavioural | B: stimulation of G15 then G13 |
Primary outcome
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
1 secondary outcome
Pain reported by the participant
Time frame: 20 minutes
Results and safety
The study was stopped early (reason given: Investigator's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 38350937Sagui 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel SAGUI, MD principal investigator
Hôpital Européen Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stimulation of G13 then G15 and stimulation of G15 then G13 in people with Vasoconstriction Disorder of Extremities, run by Hôpital Européen Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin temperature changes (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.