ObesityOBESITENCT02648191
Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery
A study testing NeuroCoach II Stim in people with Obesity and Bariatric Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Bariatric Surgery
- What is being tested?
- NeuroCoach II Stim
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2016to 1 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any obese patient consulting for bariatric surgery with BMI ≥ 35 and comorbidities or with BMI ≥ 40
- Consent Form signed
Who cannot join
- 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
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- History of Stroke
- Severe respiratory insufficiency
- Allergy in the Rhodium and in the gold
- Surgery of the vagus nerve
- Pregnant patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Bariatric Surgery
- Being tested
- NeuroCoach II Stim
- Keywords
- Obesity, Bariatric Surgery, No invasive intra-auricular vagus nerve stimulation, Weight loss, Autonomic nervous system
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroCoach II StimDevice
Also called NeuroCoach II Stim, NBA Techno, France
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 StimDevice
Also called NeuroCoach II Stim, NBA Techno, France
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.
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Experimental | Not described Receives: Device: NeuroCoach II Stim |
| Inactive stimulation | Sham comparator | Not described Receives: Device: NeuroCoach II Stim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
the weight (kg) is measured after 6 months of noninvasive stimulation.
Measured: at 6 months
Secondary outcomes (13)
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)
Measured: 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.
Measured: at 3, 6, 9 and 12 months
Apnea-hypopnea index (AHI)
AHI is analyzed by a polysomnography in an outpatient setting.
Measured: at 3, 6, 9 and 12 months
Patient Health Questionnaire-9 (PHQ-9)
It is a anxiety scale
Measured: at 3, 6, 9 and 12 months
Blood pressure
Measured: at 1, 3, 6, 9 and 12 months
Octanoylated ghrelin hormone
Patients will be subjected to blood samplings
Measured: at 3, 6, 9 and 12 months
Glucagon-like peptide-1 hormone (GLP1)
Patients will be subjected to blood samplings
Measured: at 3, 6, 9 and 12 months
Peptide tyrosine tyrosine hormone (PYY)
Patients will be subjected to blood samplings
Measured: 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
Measured: at 3, 6, 9 and 12 months
Serum insulin level
Patients will be subjected to blood samplings
Measured: at 3, 6, 9 and 12 months
Glycemia
Patients will be subjected to blood samplings
Measured: at 3, 6, 9 and 12 months
Glycated hemoglobin
Patients will be subjected to blood samplings
Measured: 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.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study start2 Mar 2016
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Why it stopped: Lack of inclusion and departure of the investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Radwan KASSIR, MD, Principal investigator, CHU de St Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648191
- Sponsor's protocol ID
- 1508013
- Other IDs
- 2015-A00253-46
- Acronym
- OBESITE
- Status last verified
- Jul 2018
- First submitted
- 5 Jan 2016
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Treatment With Noninvasive Intra-auricular Vagus Nerve Stimulation Pending Bariatric Surgery. A Randomized, Controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT02648191
- Acronym / sponsor ID
- OBESITE / 1508013
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Obesity, Bariatric Surgery, No invasive intra-auricular vagus nerve stimulation, Weight loss, Autonomic nervous system
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion and departure of the investigator
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 6 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Experimental | Device: NeuroCoach II Stim |
| Inactive stimulation | Sham comparator | Device: NeuroCoach II Stim |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any obese patient consulting for bariatric surgery with BMI ≥ 35 and comorbidities or with BMI ≥ 40
- Consent Form signed
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroCoach II StimAlso: NeuroCoach II Stim, NBA Techno, FranceA 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. | Device | Active stimulation |
| NeuroCoach II StimAlso: NeuroCoach II Stim, NBA Techno, FranceA 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. | Device | Inactive stimulation |
Primary outcome
Weight
Time frame: at 6 months
the weight (kg) is measured after 6 months of noninvasive stimulation.
13 secondary outcomes
Heart rate variability (HRV)
Time frame: at 3, 6, 9 and 12 months
Systemic inflammation
Time frame: at 3, 6, 9 and 12 months
Apnea-hypopnea index (AHI)
Time frame: at 3, 6, 9 and 12 months
Patient Health Questionnaire-9 (PHQ-9)
Time frame: at 3, 6, 9 and 12 months
Blood pressure
Time frame: at 1, 3, 6, 9 and 12 months
Octanoylated ghrelin hormone
Time frame: at 3, 6, 9 and 12 months
Glucagon-like peptide-1 hormone (GLP1)
Time frame: at 3, 6, 9 and 12 months
Peptide tyrosine tyrosine hormone (PYY)
Time frame: at 3, 6, 9 and 12 months
Lipide profile (Cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglyceride)
Time frame: at 3, 6, 9 and 12 months
Serum insulin level
Time frame: at 3, 6, 9 and 12 months
Glycemia
Time frame: at 3, 6, 9 and 12 months
Glycated hemoglobin
Time frame: at 3, 6, 9 and 12 months
Adverse effects
Time frame: at 12 months
Results and safety
The study was stopped early (reason given: Lack of inclusion and departure of the investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Radwan KASSIR, MD principal investigator
CHU de St Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroCoach II Stim in people with Obesity and Bariatric Surgery, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion and departure of the investigator). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2018.