A Trial of Transcranial Magnetic Stimulation in the Treatment of Functional Dyspepsia
NCT06559748 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS
Last updated 2024-08-19
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.
Conditions
- Functional Dysphonia
Interventions
- DEVICE
-
transcranial magnetic thetaburst stimulation (TBS)
TBS group: iTBS was administered to stimulate RMFC, 80-100% RMT, 10 times a course, twice a day, for a total of 5 days; Conventional drugs group: pantoprazole 40 mg orally once a day; itopride 50 mg orally three times a day; treatment for 4 weeks. (Standard medication regimen)
Sponsors & Collaborators
-
Second Affiliated Hospital, School of Medicine, Zhejiang University
lead OTHER
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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