Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery

Study Overview
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Brief Summary
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Faced with the current obesity epidemic, new avenues of research into effective weight loss must be developed. Among the possible actions on obesity, vagus nerve stimulation has been shown in several studies to be effective in treating epilepsy or depression, at the same time inducing weight loss in those patients. Vagus nerve stimulation has also shown to be effective on weight loss in experimental animal studies. Vagus nerve stimulation has never been attempted in obese patients awaiting bariatric surgery.

Detailed Description
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The primary objective is to demonstrate the benefit of transcutaneous vagus nerve stimulation in obese subjects awaiting surgery. Secondary objectives include, among others, the risk factors related to obesity, systemic micro-inflammation, insulin and lipid profile.

Official Title
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Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery. A Randomized, Controlled, Double-blind Trial

Conditions
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Obesity, Bariatric Surgery

Intervention / Treatment
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* Device: NeuroCoach II Stim
* Device: NeuroCoach II Stim


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any obese patient consulting for bariatric surgery with BMI ≥ 35 and comorbidities or with BMI ≥ 40 Consent Form signed Exclusion Criteria: Permanent atrial fibrillation Patient on treatment that could influence measurement of Autonomic Nervus System (ANS) activity (eg. anti-arrhythmics). For patients previously operated (by any technique), an interval of at least 6 months since the surgery must be observed Pacemaker Serious cardiac pathology History of myocardial infarction History of Stroke Severe respiratory insufficiency Allergy in the Rhodium and in the gold Surgery of the vagus nerve Pregnant patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active stimulation<br> | Device: NeuroCoach II Stim<br>* A noninvasive vagus nerve stimulator consists of two components. An electrode is placed in the left ear concha and will be used by the patient for 4-5 hours per day in segments of 1 hour minimum. For this intervention, the stimulations are active.<br>* Other names: NeuroCoach II Stim, NBA Techno, France;|
| Sham Comparator: Inactive stimulation<br> | Device: NeuroCoach II Stim<br>* A noninvasive vagus nerve stimulator consists of two components. An electrode is placed in the left ear concha and will be used by the patient for 4-5 hours per day in segments of 1 hour minimum. For this intervention, the stimulations are inactive.<br>* Other names: NeuroCoach II Stim, NBA Techno, France;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | the weight (kg) is measured after 6 months of noninvasive stimulation. | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate variability (HRV) | HRV is measured by a 24H-Holter Electrocardiography (ECG). It is a composite outcome : the standard deviation of NN intervals (SDNN) the proportion of number of pairs of successive NNs that differ by more than 50 ms, divided by total number of NNs (pNN50) high frequency (HF) low frequency (LF) very low frequency (VLF) | at 3, 6, 9 and 12 months | 
| Systemic inflammation | Markers of systemic inflammation will be measured on centrifuged serum for C-reactive protein (CRP) and by immuno microassay using the Luminex method for InterLeukin (IL)-6 and IL-17. | at 3, 6, 9 and 12 months | 
| Apnea-hypopnea index (AHI) | AHI is analyzed by a polysomnography in an outpatient setting. | at 3, 6, 9 and 12 months | 
| Patient Health Questionnaire-9 (PHQ-9) | It is a anxiety scale | at 3, 6, 9 and 12 months | 
| Blood pressure |  | at 1, 3, 6, 9 and 12 months | 
| Octanoylated ghrelin hormone | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months | 
| Glucagon-like peptide-1 hormone (GLP1) | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months | 
| Peptide tyrosine tyrosine hormone (PYY) | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months | 
| Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride) | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months | 
| Serum insulin level | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months | 
| Glycemia | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months | 
| Glycated hemoglobin | Patients will be subjected to blood samplings | at 3, 6, 9 and 12 months | 
| Adverse effects | Local and systemic adverse effects will be described at each consultation. In particular, patients will be informed that they can call the investigator if they have any questions or to report any effects that seem unusual. | at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Bariatric Surgery, No invasive intra-auricular vagus nerve stimulation, Weight loss, Autonomic nervous system