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

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Bariatric Surgery

Obesity

Treatments

Device: NeuroCoach II Stim

Study type

Interventional

Funder types

Other

Identifiers

NCT02648191

2015-A00253-46 (Other Identifier)

1508013

Details and patient eligibility

About

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.

Full 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.

Enrollment

27 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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