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Clinical study of transauricular vagus nerve stimulation for the treatment of inflammatory bowel disease

Clinical efficacy study of percutaneous auricular vagus nerve stimulation in the treatment of mild-to-moderately active Crohn's disease

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105702
Enrollment
Unknown
Registered
2025-07-09
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

group A:In group A, patients were treated with taVNS, sham taVNS, and taVNS in alternating cycles, with the specific regimen of 1-4 weeks of taVNS, 5-8 weeks of sham taVNS, and 9-12 weeks of taVNS
group B:Patients in group B were treated with sham taVNS for 1 cycle, and then followed by 2 consecutive cycles of taVNS therapy, with the specific regimen of 1-4 weeks of sham taVNS, starting from th

Sponsors

Yancheng TCM Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Eligible patients aged 18-60 years (18 450 is defined as severe; A CDAI score of 8 mg/L or fecal calprotectin FC > 200 µg/L is defined as disease activity.

Exclusion criteria

Exclusion criteria: 1. History of serious intestinal complications or surgery: the patient has serious complications such as intestinal perforation and intestinal obstruction, or has undergone intestinal resection surgery in the past. The patient has recently (within 6 months) undergone other major surgical treatment; 2. Heart disease or diseases that affect heart rate variability (HRV): Patients have serious cardiovascular diseases (such as heart failure, arrhythmia, etc.), which may affect HRV measurement. Patients have a pacemaker because it may interfere with taVNS; 3. History of neurological diseases or epilepsy: patients with a history of central nervous system diseases or epilepsy; 4. History of psychiatric illness: having a serious psychiatric illness (such as schizophrenia, major depression, bipolar disorder, etc.) that may interfere with the evaluation of the results of the study; 5. Pregnant or lactating females; 6. Other serious chronic diseases: patients with severe liver and kidney insufficiency, or other serious chronic diseases that are not suitable for participating in the study, such as diabetic complications, chronic obstructive pulmonary disease, etc.;

Design outcomes

Primary

MeasureTime frame
CRP;FC;CDAI score;

Secondary

MeasureTime frame
Heart rate variability;score of Inflammatory Bowel Disease Questionnaire;

Countries

China

Contacts

Public ContactXu Su

Yancheng TCM Hospital

xstcm81@126.com+86 139 2180 9866

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026