Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-03-01 @ 12:23 AM
Study NCT ID:
NCT04130893
Status:
TERMINATED
Last Update Posted:
2025-09-25
First Post:
2019-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.\n\nDuring the second and third sessions, Two different auricular stimuli will be done to the ear during the hand immersion test.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': "Investigator's decision", 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2019-10-16', 'studyFirstSubmitQcDate': '2019-10-16', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sinus variability', 'timeFrame': '20 minutes', 'description': 'measured by cardiofrequency meter(ACTIWAVE ®)'}], 'primaryOutcomes': [{'measure': 'Skin temperature changes', 'timeFrame': '20 minutes', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Pain reported by the participant', 'timeFrame': '20 minutes', 'description': 'Measured by visual analogue scale; this scale ranges from 0 to 10; 0 being no pain, 10 being excruciating pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ear acupuncture, auricular acupuncture'], 'conditions': ['Vasoconstriction Disorder of Extremities']}, 'referencesModule': {'references': [{'pmid': '38350937', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nSome 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.\n\nHowever, 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.\n\nIn 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.', 'detailedDescription': "Main objective: to measure the physiological impact of two auricular stimuli on the same innervation territory but with opposite actions according to traditional therapies.\n\nAn 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.\n\nSecondary objectives:\n\n* Determine, by sinus variability analysis, the intensity of the sympathetic and parasympathetic cardiac response of mechanical stimulation of the ear concha.\n* Determine the existence of a blockage of the sympathetic reaction on cutaneous vasoconstriction after mechanical stimulation of the ear concha.\n* Measure the relationship between sinus variability and paradoxical skin vasodilation after exposure to cold, as considered in the protocol.\n\nTo 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThe study will consist of 3 sessions, as shown in the figure below. This is a prospective crossover study.\n\nDuring 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.\n\nIn 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy volunteers, male and female, aged 18 to 60 years\n* BMI (Body mass index) \\<=30\n* Not participating in another clinical study with an investigational product\n\nExclusion Criteria:\n\n* Drug treatment for cardiological, neurological or anticoagulant purposes\n* History of diabetes, known neuropathy, high blood pressure, heart rhythm disorders, syncope or palpitation\n* Known cryoglobulinemia\n* Subject with Raynaud's syndrome\n* Intra-auricular device of the piercing type,\n* Psychoactive substance use, excessive alcohol consumption (\\>2 units per day chronically or \\>6 units per day recreationally) and tobacco (\\>5 cigarettes per day)\n* Subject unable to read French\n* Subject covered by Articles L1121-5 to 1121-8 of the Public Health Code, namely:\n* Pregnant, postpartum and breastfeeding women\n* Persons deprived of their liberty by a judicial or administrative decision\n* Persons undergoing psychiatric care under Articles L3112-1 and L3113-1 who are not covered by the provisions of Article L1121-8\n* Minors\n* Persons of full age who are subject to a legal protection measure or who are unable to express their consent"}, 'identificationModule': {'nctId': 'NCT04130893', 'acronym': 'AURIX', 'briefTitle': 'Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Européen Marseille'}, 'officialTitle': 'Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)', 'orgStudyIdInfo': {'id': '18-36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A stimulation of G13 then G15', 'description': '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', 'interventionNames': ['Behavioral: stimulation of G13 then G15']}, {'type': 'EXPERIMENTAL', 'label': 'B: stimulation of G15 then G13', 'description': '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', 'interventionNames': ['Behavioral: stimulation of G15 then G13']}], 'interventions': [{'name': 'stimulation of G13 then G15', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['A stimulation of G13 then G15']}, {'name': 'stimulation of G15 then G13', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['B: stimulation of G15 then G13']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13003', 'city': 'Marseille', 'state': 'PACA', 'country': 'France', 'facility': 'Hôpital Européen Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'overallOfficials': [{'name': 'Emmanuel SAGUI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Européen Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Européen Marseille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aix Marseille Université', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}