Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals.
taVNS
1 other identifier
interventional
54
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2017
CompletedFirst Posted
Study publicly available on registry
July 14, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedJuly 14, 2017
July 1, 2017
1 year
July 11, 2017
July 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of 40% of food craving symptoms
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 Outcomes (3)
Decrease of 10% of BMI and hip/waist ratio
Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Improve metabolic profile.
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).
Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Study Arms (2)
Active-taVNS
ACTIVE COMPARATORSham-taVNS
SHAM COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of São Paulo
São Paulo, 04038-020, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ruth B Grigolon, Master
Federal University of São Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master
Study Record Dates
First Submitted
July 11, 2017
First Posted
July 14, 2017
Study Start
October 1, 2017
Primary Completion
October 1, 2018
Study Completion
October 1, 2019
Last Updated
July 14, 2017
Record last verified: 2017-07