An expanded access record providing transcranial magnetic thetaburst stimulation （TBS） in Functional Dysphonia, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Temporarily not available. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-19.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Expanded access
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.
Background:
Functional dyspepsia (FD) is a prevalent gastrointestinal disorder characterized by upper abdominal discomfort, including symptoms such as pain, bloating, early satiety, belching, and nausea. The etiology of FD is multifactorial, with psychosocial factors playing a significant role in its development. Recent advances in understanding the brain-gut axis have highlighted the potential of non-invasive neuromodulation techniques, such as Transcranial Magnetic Stimulation (TMS), to modulate brain activity and alleviate FD symptoms.
TMS, particularly theta burst stimulation (TBS), has shown promise in treating various neurological and psychiatric disorders. This study aims to explore the efficacy of TBS in improving both gastrointestinal symptoms and associated psychological symptoms in patients with FD, providing a novel therapeutic option for this challenging condition.
Objective:
The primary objective of this study is to compare the efficacy of TBS, sham TBS, and conventional pharmacological treatments in alleviating the symptoms of functional dyspepsia. The study seeks to determine whether TBS can offer superior symptom relief compared to standard treatment methods.
Study Design:
This is a single-center, randomized controlled clinical trial with 2 parallel arms: TBS treatment, and conventional drug therapy. Participants will be randomly assigned to one of the 2 groups in a 1:1 ratio. The study will be conducted over two years, from November 1, 2023, to October 31, 2025.
Intervention:
Participants:
The study will enroll 150 adult outpatients (aged 18-70 years) diagnosed with functional dyspepsia according to the Rome IV criteria. Participants will be screened based on specific inclusion and exclusion criteria and will provide informed consent before enrollment.
Data Management and Statistical Analysis:
All data will be collected and analyzed using SPSS 19.0 software. The analysis will include t-tests for normally distributed data and non-parametric tests for non-normally distributed data. The study will also employ multifactor ANOVA to assess the impact of various factors on treatment outcomes.
Ethical Considerations:
The study will be conducted in accordance with ethical standards, ensuring participant confidentiality and safety. Adverse events will be closely monitored and reported to relevant regulatory bodies.
This study aims to provide evidence for the clinical efficacy of TBS in treating FD, potentially offering a new therapeutic approach for managing brain-gut axis-related disorders.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
Browse Dysphonia studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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Second Affiliated Hospital, School of Medicine, Zhejiang University →