Ear nerve stimulation added to lifestyle changes for weight loss
Tests ear nerve stimulation with lifestyle changes in adults with obesity who lost little weight.
Plain-language title generated from the registry record
Registry title: Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Lifestyle Intervention
Key facts
- Where
- Nanjing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 50 years old?
Source: NCT07630597, who can take part
Where in China
- Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical SchoolNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Trial code
- NCT07630597
- Record updated
- 5 June 2026
- Original description
This single-center, randomized, single-blind, sham-controlled pilot study aims to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight/obese patients who show a poor weight loss response to lifestyle intervention. Participants who achieve no more than 5% weight loss after 12 weeks of lifestyle intervention will be randomized to receive either taVNS plus lifestyle intervention or sham stimulation plus lifestyle intervention for an additional 12 weeks. The primary objective is to compare the percent change in body weight from baseline between the two groups after 12 weeks of intervention. Secondary objectives include evaluation of changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.Read full original descriptionShow less
Transcutaneous Auricular Vagus Nerve Stimulation as an Adjunctive Treatment for Overweight/Obese Patients With Poor Weight Loss Response to Lifestyle Intervention: A Single-Center, Randomized, Sham-Controlled Pilot Study
This single-center, randomized, single-blind, sham-controlled pilot study aims to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight/obese patients who show a poor weight loss response to lifestyle intervention. Participants who achieve no more than 5% weight loss after 12 weeks of lifestyle intervention will be randomized to receive either taVNS plus lifestyle intervention or sham stimulation plus lifestyle intervention for an additional 12 weeks. The primary objective is to compare the percent change in body weight from baseline between the two groups after 12 weeks of intervention. Secondary objectives include evaluation of changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.
Inclusion: Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period; Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period; Current body mass index (BMI) ≥28 kg/m², or BMI ≥24 kg/m² with at least one weight-related comorbidity (e.g., hypertension or fatty liver disease); Willingness to provide written informed consent.
Exclusion: Use within the past 3 months of medications that may significantly affect body weight, including glucocorticoids and antipsychotic agents; Presence of diseases that may substantially affect body weight homeostasis, including Cushing's syndrome, uncontrolled thyroid disease (thyroid-stimulating hormone >6.0 mIU/L or <0.4 mIU/L), malignancy, or similar conditions; Skin infection or damage involving the auricular area; Women planning pregnancy in the near future; Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.