TEMPORARILY_NOT_AVAILABLENot Applicable

A Trial of Transcranial Magnetic Stimulation in the Treatment of Functional Dyspepsia

Plain-language summary

The goal of this clinical trial is to learn if theta burst stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), can treat functional dyspepsia (FD) and compare its effectiveness against conventional drug treatments in patients diagnosed with FD. The main questions it aims to answer are: Does TBS improve FD-related symptoms and associated mental health conditions such as anxiety and depression? How does the effectiveness of TBS compare to conventional drug treatments for FD? Researchers will compare TBS treatment, sham TBS treatment, and conventional drug treatment to see if TBS is effective in treating FD. Participants will: Undergo TBS or sham TBS treatment, or take conventional medications as prescribed. Have their FD symptoms, anxiety, and depression levels assessed before and after the treatment. Be evaluated at various intervals (Day 3, Month 1, Month 3, Month 6) for symptom improvement and side effects. Participants are adults aged 18-70, diagnosed with FD, and willing to participate in this study. They will be randomly assigned to one of the three groups: TBS, sham TBS, or conventional drug treatment, with an equal number of participants in each group. The study will be conducted over two years, from November 1, 2023, to October 31, 2025, at the Second Affiliated Hospital of Zhejiang University School of Medicine.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Aged 18 to 70 years old, regardless of gender, outpatients.
. Meets the Rome IV diagnostic criteria for functional dyspepsia in gastroenterology (2016 edition).
. There are symptoms of postprandial fullness discomfort, early satiety discomfort, mid-upper abdominal pain, and mid-upper abdominal burning discomfort, with at least one score (degree + frequency) ≥ 4 points; the total score is ≥ 10 points. Note: See the case report form for the scoring table.
. Agree to participate in this clinical trial and sign the informed consent form.

Exclusion criteria

. Those who suffer from organic gastrointestinal diseases such as reflux esophagitis, peptic ulcer, gastrointestinal tumors, etc., or who are suspected of having intestinal obstruction.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

Trial details

NCT IDNCT06559748

SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Sponsor typeOTHER

Study typeEXPANDED_ACCESS

View on ClinicalTrials.gov More Functional Dysphonia trials