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

NCT06559748 | Unknown

• 1 other identifier: 2023-0802
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Functional Dysphonia，Transcranial Magnetic Stimulation

Interventions

transcranial magnetic thetaburst stimulation （TBS） DEVICE

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）

Also known as: Conventional drugs

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Those who suffer from organic gastrointestinal diseases such as reflux esophagitis, peptic ulcer, gastrointestinal tumors, etc., or who are suspected of having intestinal obstruction.
• Patients with intracranial hypertension, epilepsy, severe heart disease, other serious physical diseases or cognitive dysfunction; pregnant and lactating women.
• ALT and AST are greater than 1.5 times the normal value, total bilirubin exceeds 1.5 times the upper limit of the normal value, and creatinine exceeds the upper limit of the normal value;
• Suspected or confirmed history of drug or alcohol abuse;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 19, 2024
• Last Updated: August 19, 2024

Record last verified: 2024-07