Actively Recruiting
Optimization of taVNS Intervention Strategies for Refractory Constipation
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-15
100
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) works to treat refractory constipation in adults. It will also learn about the safety and tolerability of taVNS. The main questions it aims to answer are: Does taVNS improve constipation symptoms, as measured by the change in complete spontaneous bowel movements per week (ΔCSBMs/week) from baseline to post-treatment? What medical problems or side effects do participants have when receiving taVNS? Does taVNS reduce the need for rescue laxatives? Researchers will compare active taVNS to sham taVNS to see if taVNS works to treat refractory constipation. Participants will: Be randomly assigned (double-blind) to receive active taVNS or sham taVNS for 20 days Receive stimulation twice daily, 30 minutes per session, with a 12-hour interval between sessions Receive stimulation at 30 Hz with 200 μs pulse width, delivered to the left cymba conchae Keep a daily diary of bowel habits and symptoms, including CSBMs, and rescue laxative use (bowel movements occurring within 24 hours after rescue laxative use will not be counted as CSBMs)
CONDITIONS
Official Title
Optimization of taVNS Intervention Strategies for Refractory Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of functional constipation by Rome IV criteria
- During 2-week screening, 2 or fewer complete spontaneous bowel movements per week
- History of 3 or more months of constipation treatment with inadequate response
- Age between 18 and 80 years
- Able and willing to follow study procedures including stimulation and diary
- Not participating in another interventional clinical trial during the study
- Provides written informed consent
You will not qualify if you...
- Organic or secondary causes of constipation such as gastrointestinal diseases, endocrine/metabolic or neurological disorders
- Current use of medications causing constipation that cannot be stopped or kept stable
- History of opioid use disorder or chronic opioid use
- Severe psychiatric disorders or risk of self-harm requiring urgent intervention
- Contraindications to taVNS or ear stimulation including ear disease or skin lesions
- Presence of implanted electronic medical devices or conditions contraindicating electrical stimulation
- Pregnant or breastfeeding women
- Serious unstable medical conditions that could interfere with participation or outcomes
- Cognitive or communication impairments preventing consent or diary completion
- Any condition the investigator judges makes participation unsuitable
AI-Screening
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Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, China
Actively Recruiting
Research Team
Z
Zhifeng Zhao, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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