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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity; Bariatric Surgery
• Intervention / Treatment: Device: NeuroCoach II Stim; Device: NeuroCoach II Stim

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • St Etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active stimulation	Device: NeuroCoach II Stim; 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.; Other Names: NeuroCoach II Stim, NBA Techno, France; Device: NeuroCoach II Stim; 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.; Other Names: NeuroCoach II Stim, NBA Techno, France
Sham Comparator: Inactive stimulation	Device: NeuroCoach II Stim; 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.; Other Names: NeuroCoach II Stim, NBA Techno, France; Device: NeuroCoach II Stim; 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.; Other Names: NeuroCoach II Stim, NBA Techno, France

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Fondation de l'Avenir
• Investigators: Principal Investigator: Radwan KASSIR, MD, CHU de St Etienne

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: January 5, 2016
• First Submitted That Met QC Criteria: January 5, 2016
• First Posted (Estimate): January 6, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Obesity; Weight loss; Autonomic nervous system; Bariatric Surgery; No invasive intra-auricular vagus nerve stimulation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 1508013; 2015-A00253-46 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No