Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals. (taVNS)

July 12, 2017 updated by: Ruth Bartelli Grigolon, Federal University of São Paulo

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals: a Randomized, Sham-controlled, Double Blind Clinical Trial.

Background: Obesity is one of the most important diseases around the globe; with a continuous increase and public health concern. Current treatments present some limitations. Craving is a symptom usually noticeable and has been described as a "strong desire or urge to use", especially with foods. The vagus nerve and its relations to the neurocircuitry of the reward system play essential roles in food intake regulation and this can be done transcutaneously trough the auricular branch of the vagus nerve (taVNS). Based on the neurobiology of food craving and on the initial data on taVNS demonstrating safety and efficacy in open-label and randomized sham controlled trials, the investigators propose the first randomized, sham controlled, triple-blind trial on taVNS for food craving in obesity.

Methods: This will be a two-arm, triple-blinded, randomized controlled trial with 54 subjects with food craving assigned to either: 1) a 10-session treatment protocol of real taVNS, or 2) a 10-session treatment protocol of sham taVNS, besides qualitative electroencephalogram (qEEG) and heart rate variability (HRV). Participants will be evaluated for primary outcome measures (Food Craving Questionnaire - State [FCQ-S] and Food Craving Questionnaire - Trait [FCQ-T]) before and after intervention, with a follow-up visit of 30 days after the end of treatment. A comparison between sham and active groups will be performed in three occasions [baseline (T1), at the end of the stimulation protocol (T2) and 30 days after the last day of stimulation (T3)].

Discussion: Given the epidemiological situation and economic and social burdens, the possibility of modulating the reward system neurocircuitry trough the vagus nerve with an easy-to-use, low-cost, safe and potential at-home use could represent a breakthrough in treating obesity. The investigators hypothesized that food craving in obese individuals would decrease at least 50%, as well as their intake of high fat, high sugar and processed food, commonly described as palatable foods. Beyond that, the investigators expect that these individuals would improve anxiety symptoms.

Study Overview

Status

Status

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Unknown

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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Study Contact

Study Contact

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Study Contact Backup

Study Locations

  • Brazil
      • São Paulo, Brazil, 04038-020
        • Federal University of São Paulo

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI)>29
  • Age between 18 and 55 years old
  • Food Craving Questionnaire-State and Trait (FCQ-S and FCQ-T)>108
  • Agreement to participate and sign the informed consent term before any procedure is conducted.

Exclusion Criteria:

  • History of head injury or epilepsy
  • Body metallic implants and pacemaker
  • Current use or in the previous six months of psychotropic or anorexigenic medications, recreational drugs and/or participation in weight-loss programs
  • Pregnancy or breastfeeding
  • Indication of hospitalization
  • Substance dependence
  • Psychiatric disorder, except for anxiety disorders
  • Personality disorders
  • Suicidal ideation
  • Non-controlled clinical comorbidities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active-taVNS
Device: Active-taVNS
Stimulation will be performed using the Neurodyn II (Ibramed) equipment approved by the national regulatory agency (ANVISA). The following parameters will be used: 120 Hz (hertz) of frequency, 250 μs of pulse duration and 12 milliamperes of intensity for a continuous stimulation for 30 minutes. This intensity corresponds to a non-painful mild paresthesia without muscle contraction previously described and evaluated. The 25 cm² (centimeters) electrodes will be positioned over the retroauricular area. A total of 10 sessions (one session per day during 10 week-days) will be performed. Every session will be followed by an interview with a trained psychiatrist to evaluate possible adverse effects and guarantee safety issues regarding the study itself.
Sham Comparator: Sham-taVNS
Device: Sham-taVNS
Regarding sham protocol, the device will be turned off after 60 seconds of stimulation without the knowledge of the patient. After this initial period, the referred paresthesia seems to diminish due to nerve accommodation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction of 40% of food craving symptoms
Time Frame: Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Changes in food craving will be evaluated by the Brazilian version of the FCQ-S and FCQ-T. A comparison between sham and active groups will be performed in three occasions.
Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Decrease of 10% of BMI and hip/waist ratio
Time Frame: Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Improve metabolic profile.
Time Frame: Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Improve anxiety symptoms evaluated by the Inventory for Depressive Symptoms (Self-Report version).
Time Frame: Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of São Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ruth B Grigolon, Master, Federal University of São Paulo

Study record dates

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Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 51355115.8.0000.5479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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