Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals. (taVNS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03217929|
Recruitment Status : Unknown
Verified July 2017 by Ruth Bartelli Grigolon, Federal University of São Paulo.
Recruitment status was: Not yet recruiting
First Posted : July 14, 2017
Last Update Posted : July 14, 2017
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment||Phase|
|Obesity Craving||Device: Active-taVNS Device: Sham-taVNS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals: a Randomized, Sham-controlled, Double Blind Clinical Trial.|
|Estimated Study Start Date :||October 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2019|
|Active Comparator: 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||
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.
- 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.
- 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. ]
- 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. ]
- 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. ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03217929
|Contact: Ruth B Grigolon, Masterfirstname.lastname@example.org|
|Contact: Alisson P Trevizol, PhDemail@example.com|
|Federal University of São Paulo|
|São Paulo, Brazil, 04038-020|
|Contact: Ruth B Grigolon, Master 5519998639341 firstname.lastname@example.org|
|Contact: Alisson P Trevizol, PhD 5511996044825 email@example.com|
|Principal Investigator:||Ruth B Grigolon, Master||Federal University of São Paulo|
|Responsible Party:||Ruth Bartelli Grigolon, Master, Federal University of São Paulo|
|Other Study ID Numbers:||
|First Posted:||July 14, 2017 Key Record Dates|
|Last Update Posted:||July 14, 2017|
|Last Verified:||July 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|