NCT02648191

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 2, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

July 19, 2018

Status Verified

July 1, 2018

Enrollment Period

1.9 years

First QC Date

January 5, 2016

Last Update Submit

July 17, 2018

Conditions

ObesityBariatric Surgery

Keywords

ObesityBariatric SurgeryNo invasive intra-auricular vagus nerve stimulationWeight lossAutonomic nervous system

Outcome Measures

Primary Outcomes (1)

  • Weight

    the weight (kg) is measured after 6 months of noninvasive stimulation.

    at 6 months

Secondary Outcomes (13)

  • Heart rate variability (HRV)

    at 3, 6, 9 and 12 months

  • Systemic inflammation

    at 3, 6, 9 and 12 months

  • Apnea-hypopnea index (AHI)

    at 3, 6, 9 and 12 months

  • Patient Health Questionnaire-9 (PHQ-9)

    at 3, 6, 9 and 12 months

  • Blood pressure

    at 1, 3, 6, 9 and 12 months

  • +8 more secondary outcomes

Study Arms (2)

Active stimulation

EXPERIMENTAL
Device: NeuroCoach II Stim

Inactive stimulation

SHAM COMPARATOR
Device: NeuroCoach II Stim

Interventions

NeuroCoach II StimDEVICE

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.

Also known as: NeuroCoach II Stim, NBA Techno, France
Active stimulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any obese patient consulting for bariatric surgery with BMI ≥ 35 and comorbidities or with BMI ≥ 40
  • Consent Form signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

ObesityWeight Loss

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Radwan KASSIR, MD

    CHU de St Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 6, 2016

Study Start

March 2, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

July 19, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)