Actively Recruiting
A Randomized Controlled Trial of Transcutaneous Auricular Vagus Nerve Stimulation for Refractory Constipation in Adults
Led by Xijing Hospital of Digestive Diseases · Updated on 2026-01-15
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find out if transcutaneous auricular vagus nerve stimulation (taVNS) helps adults with refractory constipation, a condition where constipation does not improve with usual treatments. The study will also examine the safety and tolerability of taVNS. Researchers want to know if taVNS increases the number of complete spontaneous bowel movements per week, reduces the need for rescue laxatives, and what side effects or medical problems may occur during treatment. Participants will be randomly assigned to receive either active taVNS or a sham procedure that looks the same but does not provide real stimulation. Both groups will use the device twice daily for 20 days, with two 30-minute sessions each day spaced about 12 hours apart. The active stimulation is delivered to the left ear at specific settings, while the sham group receives a placebo-like procedure to keep the study blinded. During the trial, participants will keep a daily diary recording bowel habits, symptoms, and use of rescue laxatives. Researchers will monitor changes in bowel movements, symptoms of depression and anxiety, and neurological responses using EEG. The main outcome is how well baseline brain activity predicts response to treatment after 20 days. Safety and side effects will also be tracked, with the total participation lasting about three weeks.
CONDITIONS
Brief Title
Optimization of taVNS Intervention Strategies for Refractory Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of functional constipation meeting Rome IV criteria
- During 2-week screening, 2 or fewer complete spontaneous bowel movements per week
- History of at least 3 months of prior constipation treatment with inadequate response
- Age between 18 and 80 years
- Able and willing to comply with study procedures including device use and diary
- Not participating in another interventional clinical trial
- Provides written informed consent
You will not qualify if you...
- Organic or secondary causes of constipation such as inflammatory bowel disease or tumors
- Endocrine or metabolic disorders causing constipation (e.g., uncontrolled hypothyroidism, diabetes)
- Neurological disorders affecting bowel function (e.g., Parkinson's disease, spinal cord disorders)
- Current use of medications causing constipation that cannot be stabilized or discontinued
- History of opioid use disorder or chronic opioid use
- Severe psychiatric conditions requiring urgent intervention or risk of self-harm
- Ear disease or skin infection at stimulation site or other contraindications to taVNS
- Implanted electrical medical devices like pacemakers
- Pregnant or breastfeeding women
- Severe or unstable medical conditions interfering with participation
- Cognitive or communication impairments preventing consent or diary completion
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 consecutive days
Participants receive active or sham transcutaneous auricular vagus nerve stimulation (taVNS) twice daily for 20 consecutive days, with two 30-minute sessions per day separated by approximately 12 hours.
Daily device use at home with monitoring
Trial Site Locations
Total: 1 location
1
Xijing Hospital
Xi'an, China
Actively Recruiting
Research Team
Z
Zhifeng Zhao, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here