Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559748
Status:
TEMPORARILY_NOT_AVAILABLE
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
A Trial of Transcranial Magnetic Stimulation in the Treatment of Functional Dyspepsia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-arm Randomized Controlled Trial of Transcranial Magnetic Theta-burst Stimulation in the Treatment of Functional Dyspepsia
Status:
TEMPORARILY_NOT_AVAILABLE
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 11 ratio The study will be conducted over two years from November 1 2023 to October 31 2025
Intervention
TBS Group Participants will receive iTBS stimulation of the right medial frontal cortex RMFC at 80-100 of their resting motor threshold RMT with 10 sessions per course administered twice daily for five days
Conventional Drug GroupParticipants will receive pantoprazole 40 mg orally once daily and itopride 50 mg orally three times daily for four weeks
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 190 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
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 11 ratio The study will be conducted over two years from November 1 2023 to October 31 2025
Intervention
TBS Group Participants will receive iTBS stimulation of the right medial frontal cortex RMFC at 80-100 of their resting motor threshold RMT with 10 sessions per course administered twice daily for five days
Conventional Drug GroupParticipants will receive pantoprazole 40 mg orally once daily and itopride 50 mg orally three times daily for four weeks
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 190 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: