Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409078
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-07
Brief Title:
Repeated Transcranial Magnetic Stimulation Relieve Chronic Visceral Pain in IBS
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
The First Affiliated Hospital of Soochow University
Study Overview
Official Title:
Clinical Study of Repeated Transcranial Magnetic StimulationrTMS for Chronic Visceral Pain in Patients With Irritable Bowel SyndromeIBS
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective To evaluate the overall efficacy of rTMS in the treatment of irritable bowel syndrome and to explore the central mechanism of rTMS for IBS
Methods
1 Clinical efficacy evaluation of TMS for chronic visceral pain in IBS patients The 200 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS and Western medicine group Corresponding treatment was given for 1 week rTMS group received 1 Hzs 20 min for 1 week Western medicine group received pivinonium tablets orally 50 mg three times a day for 1 week Clinical assessment included symptoms stool traits mood and sleep
2 Study on the central mechanism of using fMRI to treat chronic visceral pain in IBS patients Forty cases each were included in the IBS-eligible patient group and the healthy control group and repeated transcranial magnetic stimulation treatment was given to the patient group for 1 week and the patient group underwent the assessment of clinical observational indexes IBS-SSS SAS SDS and AIS before and after the treatment and the acquisition of functional magnetic resonance data In the healthy control group clinical observation indexes SAS SDS AIS were evaluated before enrollment and functional magnetic resonance data were collected after enrollment
Conclusion
1 The clinical efficacy of rTMS for IBS is superior to that of the western drug pivoxyl bromide tablets
2 Targeted brain areas of rTMS treatment there was a positive correlation between the change in ALFF values of mPFC and the improvement in abdominal pain level score before and after treatment
Methods
1 Clinical efficacy evaluation of TMS for chronic visceral pain in IBS patients The 200 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS and Western medicine group Corresponding treatment was given for 1 week rTMS group received 1 Hzs 20 min for 1 week Western medicine group received pivinonium tablets orally 50 mg three times a day for 1 week Clinical assessment included symptoms stool traits mood and sleep
2 Study on the central mechanism of using fMRI to treat chronic visceral pain in IBS patients Forty cases each were included in the IBS-eligible patient group and the healthy control group and repeated transcranial magnetic stimulation treatment was given to the patient group for 1 week and the patient group underwent the assessment of clinical observational indexes IBS-SSS SAS SDS and AIS before and after the treatment and the acquisition of functional magnetic resonance data In the healthy control group clinical observation indexes SAS SDS AIS were evaluated before enrollment and functional magnetic resonance data were collected after enrollment
Conclusion
1 The clinical efficacy of rTMS for IBS is superior to that of the western drug pivoxyl bromide tablets
2 Targeted brain areas of rTMS treatment there was a positive correlation between the change in ALFF values of mPFC and the improvement in abdominal pain level score before and after treatment
Detailed Description:
A large number of literature has reported that repetitive transcranial magnetic stimulationrTMS can relieve chronic pain The specific mechanisms include that rTMS can change the excitability of the cerebral cortex improve cerebral blood flow and metabolism regulate neurotransmitter and gene expression and plastic changes in the nervous system
Objective
To evaluate the overall efficacy of rTMS treatment for irritable bowel syndrome including abdominal pain symptoms bowel symptoms and psychiatric symptoms anxiety depression sleep disturbance And also to explore the central mechanism of rTMS for the treatment of IBS based on functional magnetic resonance imagingfMRI of the brain
Methods
1 Clinical evaluation of the efficacy of rTMS for chronic visceral pain in IBS patients The 200 IBS patients who meet the recruitment criteria for clinical studies will be randomized into 100 patients each of the rTMS and Western medicine groups Treatment for 1 week 1 Hzs 20 min for 1 week in rTMS group 50 mg three times a day for 1 week in the western medicine group with Desutidechemical namepivoxyl bromide tablets Before and after treatment the clinical observation indicators of the two groups included symptom severity score stool character score ZUNGs anxiety self-measurement table ZUNGs depression self-measurement table Asens sleep scale and efficacy evaluation and safety evaluation were carried out at the end of 1-week treatment
2 A study of central mechanism in the treatment of chronic visceral pain in IBS patients using fMRI to detect rTMS A total of 40 patients meeting the recruitment criteria of magnetic resonance study and 40 patients in the IBS group and healthy control group were included The patient group received rTMS for 1 week the specific operation method was the same as that in the clinical efficacy evaluation section and the healthy control group did not intervene The patient group was evaluated with clinical observation indicators IBS-SSS SAS SDS AIS and fMRI data acquisition before and after treatment Clinical observation indicators SAS SDS AIS were evaluated before enrollment and fMRI data were collected after enrollment
The functional magnetic resonance data of the two groups were analyzed using the amplitude of low frequency ALFF method and the local coherence ReHo method to compare the differences in brain function between the patient group and the healthy control group before treatment as well as the changes in brain function of the patient group before and after treatment and the values of the changes in the ALFF and the ReHo of the different brain regions before and after treatment and the improvement values of the clinical observation indexes were correlated to determine the repeated transcranial magnetic target brain areas for the effect of repeated transcranial magnetic stimulation
Conclusion
1 The efficacy of rTMS in the treatment of IBS was superior to that of the western drug pivoxyl bromide tablets in improving the total IBS-SSS symptom score as well as in relieving the degree of abdominal pain decreasing the frequency of abdominal pain improving the impact of life and improving the quality of sleep
2 Differences in brain function between IBS patients and healthy subjects were detected by fMRI fMRI detected elevated low-frequency amplitude and local coherence in some neocortical brain regions which may be an important central pathologic change in IBS rTMS treatment resulted in decreased ALFF and local coherence in the mPFC brain regions in the IBS group Before and after treatment there was a positive correlation between the change in ALFF values of the mPFC and the improvement in abdominal pain level scores
Objective
To evaluate the overall efficacy of rTMS treatment for irritable bowel syndrome including abdominal pain symptoms bowel symptoms and psychiatric symptoms anxiety depression sleep disturbance And also to explore the central mechanism of rTMS for the treatment of IBS based on functional magnetic resonance imagingfMRI of the brain
Methods
1 Clinical evaluation of the efficacy of rTMS for chronic visceral pain in IBS patients The 200 IBS patients who meet the recruitment criteria for clinical studies will be randomized into 100 patients each of the rTMS and Western medicine groups Treatment for 1 week 1 Hzs 20 min for 1 week in rTMS group 50 mg three times a day for 1 week in the western medicine group with Desutidechemical namepivoxyl bromide tablets Before and after treatment the clinical observation indicators of the two groups included symptom severity score stool character score ZUNGs anxiety self-measurement table ZUNGs depression self-measurement table Asens sleep scale and efficacy evaluation and safety evaluation were carried out at the end of 1-week treatment
2 A study of central mechanism in the treatment of chronic visceral pain in IBS patients using fMRI to detect rTMS A total of 40 patients meeting the recruitment criteria of magnetic resonance study and 40 patients in the IBS group and healthy control group were included The patient group received rTMS for 1 week the specific operation method was the same as that in the clinical efficacy evaluation section and the healthy control group did not intervene The patient group was evaluated with clinical observation indicators IBS-SSS SAS SDS AIS and fMRI data acquisition before and after treatment Clinical observation indicators SAS SDS AIS were evaluated before enrollment and fMRI data were collected after enrollment
The functional magnetic resonance data of the two groups were analyzed using the amplitude of low frequency ALFF method and the local coherence ReHo method to compare the differences in brain function between the patient group and the healthy control group before treatment as well as the changes in brain function of the patient group before and after treatment and the values of the changes in the ALFF and the ReHo of the different brain regions before and after treatment and the improvement values of the clinical observation indexes were correlated to determine the repeated transcranial magnetic target brain areas for the effect of repeated transcranial magnetic stimulation
Conclusion
1 The efficacy of rTMS in the treatment of IBS was superior to that of the western drug pivoxyl bromide tablets in improving the total IBS-SSS symptom score as well as in relieving the degree of abdominal pain decreasing the frequency of abdominal pain improving the impact of life and improving the quality of sleep
2 Differences in brain function between IBS patients and healthy subjects were detected by fMRI fMRI detected elevated low-frequency amplitude and local coherence in some neocortical brain regions which may be an important central pathologic change in IBS rTMS treatment resulted in decreased ALFF and local coherence in the mPFC brain regions in the IBS group Before and after treatment there was a positive correlation between the change in ALFF values of the mPFC and the improvement in abdominal pain level scores
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None