Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Lifestyle Intervention

NCT07630597 | Recruiting

• 1 other identifier: 2026-0518-02
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight

Keywords

Obesity & Overweight; Transcutaneous Auricular Vagus Nerve Stimulation; Lifestyle Intervention; Non-responders

Outcome Measures

Primary Outcomes (1)

• Percent Change in Body Weight From Baseline

  Percent change in body weight from baseline to week 12 will be compared between the taVNS plus lifestyle intervention group and the sham stimulation plus lifestyle intervention group to evaluate the adjunctive effect of taVNS on weight reduction.

  Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (15)

• Change in Waist Circumference

  Baseline, ,Week 4, Week 8, Week 12

• Change in Body Composition and Fat Distribution

  Baseline, ,Week 4, Week 8, Week 12

• Change in Visceral Fat Area

  Baseline, ,Week 4, Week 8, Week 12

• Change in blood glucose

  Baseline, Week 12

• Change in Glycated Hemoglobin

  Baseline, Week 12

Other Outcomes (1)

• Change in Brain Biotype

  Baseline, Week 12

Study Arms (2)

taVNS Plus Lifestyle Intervention

EXPERIMENTAL

Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle intervention for 12 weeks.

Device: transcutaneous auricular vagus nerve stimulation

Sham Stimulation plus Lifestyle Intervention

SHAM COMPARATOR

Participants will receive sham stimulation in addition to standardized lifestyle intervention for 12 weeks

Device: Sham

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

Participants will receive active transcutaneous auricular vagus nerve stimulation in addition to lifestyle Intervention for 12 weeks. Active stimulation will be delivered to the left cymba conchae using an intermittent waveform (15 seconds on, 5 seconds off) at 20 Hz with a pulse width of 0.2 ms. Stimulation intensity will be titrated from 0 mA to a level that produces mild tingling without obvious discomfort, usually 1.0-2.5 mA. Stimulation will be administered twice daily for 30 minutes per session, 5 days per week, for 12 weeks.

Also known as: Lifestyle Intervention

taVNS Plus Lifestyle Intervention

Sham DEVICE

Participants will receive sham stimulation in addition to lifestyle Intervention for 12 weeks. Sham stimulation will be applied to the left tail of the helix using the same waveform parameters, stimulation intensity titration, and treatment schedule as the active group, namely twice daily for 30 minutes per session, 5 days per week, for 12 weeks.

Also known as: Lifestyle Intervention

Sham Stimulation plus Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Use within the past 3 months of medications that may significantly affect body weight, including glucocorticoids and antipsychotic agents;
• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Department of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yan Bi, MD, PhD

CONTACT

6-25-83-105302; biyan@nju.edu.cn

Tian Wei Gu, MD, PhD

CONTACT

gtw0235@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants are masked in this trial. Participants are randomly assigned to active taVNS plus lifestyle intervention or sham stimulation plus lifestyle intervention. To maintain masking, sham stimulation uses the same device, similar stimulation procedures, and the same treatment schedule as active stimulation, but is applied to a non-vagal auricular site (the left tail of the helix). Randomization codes are generated by an independent unblinded team and allocation is concealed using sealed, opaque envelopes. Emergency unblinding materials are prepared and securely retained.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 5, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)