Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals.
NCT ID: NCT03217929
Last Updated: 2017-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
54 participants
INTERVENTIONAL
2017-10-31
2019-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Auricular Vagus Stimulation in Obesity
NCT05230628
Effect of Non-invasive Vagal Nerve Stimulation on Selected Outcomes in Central Obesity
NCT07341971
Effect of Transauricular Vagus Nerve Stimulation on Postoperative Pain Management in Video Assisted Thoracic Surgery
NCT06912399
The Effect of taVNS on the Prognosis of Patients Undergoing Pancreatoduodenectomy
NCT06786923
tVNS and Obesity-related Mechanisms
NCT06954844
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Active-taVNS
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-taVNS
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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-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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Federal University of São Paulo
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Ruth Bartelli Grigolon
Master
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ruth B Grigolon, Master
Role: PRINCIPAL_INVESTIGATOR
Federal University of São Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Federal University of São Paulo
São Paulo, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
51355115.8.0000.5479
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.