ObesitytaVNSNCT03217929
Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals.
A study testing Active-taVNS in people with Obesity and Craving, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Active-taVNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2017to Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Psychiatric disorder, except for anxiety disorders
- Personality disorders
- Suicidal ideation
- Non-controlled clinical comorbidities.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of São Paulo
São Paulo, 04038-020
Ruth B Grigolon, Master, 5519998639341, rbgrigolon@gmail.com
Alisson P Trevizol, PhD, 5511996044825, alisson.trevizol@hotmail.com
About this study
Official title: 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.
- Being tested
- Active-taVNS, Sham-taVNS
- Keywords
- vagus nerve, obesity, craving, food
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active-taVNSDevice
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-taVNSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active-taVNS | Active comparator | Not described Receives: Device: Active-taVNS |
| Sham-taVNS | Sham comparator | Not described Receives: Device: Sham-taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Improve metabolic profile.
Measured: 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).
Measured: Baseline, at the end of the stimulation protocol (10 days after) and 30 days after the last day of stimulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study startOct 2017 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Bartelli Grigolon, Federal University of São Paulo
- Investigators
- Ruth B Grigolon, Master, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217929
- Sponsor's protocol ID
- 51355115.8.0000.5479
- Acronym
- taVNS
- Status last verified
- Jul 2017
- First submitted
- 11 Jul 2017
- Last updated
- 14 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Food Craving in Obese Individuals: a Randomized, Sham-controlled, Double Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT03217929
- Acronym / sponsor ID
- taVNS / 51355115.8.0000.5479
- Keywords
- vagus nerve, obesity, craving, food
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Oct 2017 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active-taVNS | Active comparator | Device: Active-taVNS |
| Sham-taVNS | Sham comparator | Device: Sham-taVNS |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active-taVNSStimulation 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. | Device | Active-taVNS |
| Sham-taVNSRegarding 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. | Device | Sham-taVNS |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth B Grigolon, Master principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active-taVNS in people with Obesity and Craving, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruth B Grigolon, Master (5519998639341, rbgrigolon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2017.