Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery
NCT ID: NCT02648191
Last Updated: 2018-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
27 participants
INTERVENTIONAL
2016-03-02
2018-02-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Non-invasive Vagal Nerve Stimulation on Selected Outcomes in Central Obesity
NCT07341971
Vagus Nerve Response in Gastroparesis Patients
NCT04207996
Noninvasive Vagus Nerve Stimulation (VNS) for Neuromotor Adaptations
NCT03628976
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals.
NCT03217929
Effects of Transcutaneous Auricular Vagus Nerve Stimulation on Obesity and Insulin Resistance
NCT04926415
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active stimulation
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.
Inactive stimulation
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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 Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Consent Form signed
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondation de l'Avenir
OTHER
Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Radwan KASSIR, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de St Etienne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Saint-Etienne
Saint-Etienne, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-A00253-46
Identifier Type: OTHER
Identifier Source: secondary_id
1508013
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.