Status:
TERMINATED
Response of the Autonomic Nervous System to Auricular Stimulation of the Vagus Nerve (x)
Lead Sponsor:
Hôpital Européen Marseille
Collaborating Sponsors:
Aix Marseille Université
Conditions:
Vasoconstriction Disorder of Extremities
Eligibility:
All Genders
18-60 years
Phase:
NA
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 co...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04130893
Start Date
January 17 2019
End Date
November 21 2019
Last Update
September 25 2025
Active Locations (1)
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1
Hôpital Européen Marseille
Marseille, PACA, France, 13003