Clinical trial NCT06409078: Repeated Transcranial Magnetic Stimulation Relieve Chronic Visceral Pain in IBS
Official title: Clinical Study of Repeated Transcranial Magnetic Stimulation(rTMS) for Chronic Visceral Pain in Patients With Irritable Bowel Syndrome(IBS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Repetitive Transcranial Magnetic Stimulation
Chronic Visceral Pain
Functional Magnetic Resonance Imaging
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Soochow University
First posted: 2024-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Hz/s, 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 stimulation(rTMS) 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 imaging(fMRI) 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 Hz/s, 20 min for 1 week in rTMS group; 50 mg three times a day for 1 week in the western medicine group with Desutide(chemical name:pivoxyl bromide tablets). Before and after treatment, the clinical observation indicators of the two groups included symptom severity score, stool character score, ZUNG's anxiety self-measurement table, ZUNG's 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.

Eligibility criteria: Inclusion Criteria:

1. Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV.
2. Age range between 18-70 years.
3. The duration of the disease is more than 6 months.
4. There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms.
5. The IBS symptom severity score at baseline must not be less than 75.
6. No pharmacological treatment (excluding emergency treatment) for IBS for at least 2 weeks prior to the start of treatment; no concurrent participation in other clinical programs.
7. Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical project.

Exclusion Criteria:

1. Be less than 18 years old or more than 70 years old.
2. Those who suffer from severe liver, kidney, hematopoietic system diseases, cardiovascular and cerebrovascular diseases, and psychiatric diseases that significantly affect cognitive function.
3. Patients with clear organic diseases of the intestinal tract; patients with diabetes, hyperthyroidism and other systemic diseases that affect the digestive tract dynamics; patients who have had a history of surgery on the anus and intestines or the abdomen.
4. The presence of the following conditions affecting the efficacy or safety judgment: ① regular use of preparations and drugs affecting gastrointestinal dynamics or function; ② treatment with other treatments and drugs that may affect the results of the judgment.
5. Those who are pregnant, breastfeeding or less than 12 months after delivery.
6. Patients with severe fear of needles, metal allergies or sensitivities, or those with pacemakers.
7. Patients who do not comply with the randomized assignment to the treatment group or have a tendency to be unstable such as poor compliance.
8. Patients who are participating in other research projects.
9. Those who do not want to sign the informed consent form.

Primary outcomes:
measure: IBS-symptom severity score
timeFrame: After 1 week of treatment
Secondary outcomes:
measure: anorectal manometry
timeFrame: the first week before starting treatment and the first week after finishing treatment
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Rui Li
role: PRINCIPAL_INVESTIGATOR
References: