Repetitive Transcranial Magnetic StimulationNCT06757491
Lf-rTMS Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea
A study testing Repetitive Transcranial Magnetic Stimulation in people with Repetitive Transcranial Magnetic Stimulation and Chronic Visceral Pain, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Objectives: To identify a central hub of visceral pain in IBS-D and elucidate the mechanism by which repetitive transcranial magnetic stimulation (rTMS) confers analgesic effects. Methods: A total of 42 IBS-D patients were recruited and randomly assigned (1:1) to the sham rTMS or the rTMS group. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Repetitive Transcranial Magnetic Stimulation, Chronic Visceral Pain, Functional Magnetic Resonance Imaging
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 25 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
All diagnoses were made by board-certified gastroenterologists. Eligible participants met the following inclusion criteria: (1) age between 18 and 75 years; (2) fulfillment of the Rome IV diagnostic criteria for IBS-D. Exclusion criteria included: (1) presence of inflammatory or other organic gastrointestinal diseases; (2) diagnosed psychiatric disorders; (3) history of anorectal, intestinal, or abdominal surgery; (4) pregnancy or lactation; (5) presence of metallic implants or cardiac pacemakers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Shuangjie Wu, +8651267972743, sdfyec@163.com
lrhcsz@163.com
About this study
Official title: Low-frequency Repetitive Transcranial Magnetic Stimulation Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea Via Inhibition of the Medial Prefrontal Cortex
Objectives: To identify a central hub of visceral pain in IBS-D and elucidate the mechanism by which repetitive transcranial magnetic stimulation (rTMS) confers analgesic effects.
Methods: A total of 42 IBS-D patients were recruited and randomly assigned (1:1) to the sham rTMS or the rTMS group. A nested cohort of 21 IBS-D participants who completed baseline fMRI assessments prior to randomization was included. Consistent with the randomization procedure，these individuals were evenly distributed between the two groups. Both participants and outcome assessors remained blinded to treatment allocation throughout the study. All patients completed the two-week intervention and were included in the final analysis.
Read the detailed description
Background：Chronic visceral pain in irritable bowel syndrome with diarrhea (IBS-D) is a profound therapeutic challenge. While aberrant central processing is implicated, the key brain regions driving this visceral pain and their suitability as neuromodulatory targets remain undefined.
Methods: Participants were randomly assigned (1:1) to the sham rTMS or rTMS group using a computer-generated randomization sequence created by an independent researcher who was not involved in recruitment, treatment, or outcome assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only after baseline evaluations were completed.
Both participants and outcome assessors were blinded to treatment allocation. The rTMS operators were not involved in data collection or analysis. For the sham condition, the coil was positioned identically over the mPFC with magnetic output disabled, and prerecorded clicking sounds were delivered to mimic the acoustic sensation of stimulation. Participants were asked not to discuss treatment sensations with assessors. Scale raters and fMRI analysts remained blinded until all analyses were finalized.
For the nested fMRI cohort, randomization and blinding procedures were identical, with group allocation revealed only after preprocessing and statistical analysis had been completed.
- Conditions
- Repetitive Transcranial Magnetic Stimulation, Chronic Visceral Pain, Functional Magnetic Resonance Imaging, IBS (Irritable Bowel Syndrome), Clinical Efficacy
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham (No Treatment)
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
A figure-of-eight coil is used to apply active low-frequency (1 Hz) rTMS to the corresponding representation area of theprefrontal cortex (mPFC). The treatment is administered for 20 minutes daily for a total of 2 weeks.
Sham (No Treatment)Device
For the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group.
| Study group | Role | What they receive |
|---|---|---|
| Sham rTMS Group | Sham comparator | For the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. Receives: Device: Sham (No Treatment) |
| rTMS Group | Active comparator | Low-frequency rTMS (1 Hz) was applied to the mPFC using a TMS stimulator at 80% resting motion threshold intensity. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral Sensitivity Index
(1) Clinical control: After the course of treatment, clinical symptoms disappear; (2) Significant effect: After the course of treatment, the symptom grading is reduced by 2 levels; (3) Effective: After the course of treatment, the symptom grading is reduced by 1 level; (4) Ineffective: After treatment, those who do not meet the above standards.
Measured: 2 weeks of treatment
Secondary outcomes (1)
IBS-symptom severity score
The criteria were based on the IBS Symptom Severity Score (IBS-SSS), a hierarchical efficacy assessment method.The IBS-SSS consists of five entries assessing the degree of abdominal pain and discomfort, frequency of bdominal pain episodes, the degree of abdominal distension and discomfort, the degree of satisfaction with bowel habits and behaviors, and the degree of impact of intestinal symptoms on life,with a total score of 500 points. A score of 75-175 is considered mild, 176-300 is moderate, and over 300 is severe. Cure was defined as a total IBS symptom severity of less than 75; efficacy was defined as 2-level improvement in total score(e.g., symptoms improved from severe to mild); validity was defined as a 1-level improvement in tatal(e.g., symptoms improved from severe to moderate or symptoms from moderate to mild); and invalidity was defined as no improvement or deterioration in total score.
Measured: 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start1 Aug 2024
- Primary completion25 Dec 2025 (estimated)
- Study completion25 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui Li, Dr., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06757491
- Sponsor's protocol ID
- 2024-KY-08
- Other IDs
- BE2023710
- Status last verified
- Nov 2025
- First submitted
- 24 Dec 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-frequency Repetitive Transcranial Magnetic Stimulation Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea Via Inhibition of the Medial Prefrontal Cortex
- ClinicalTrials.gov ID
- NCT06757491
- Acronym / sponsor ID
- 2024-KY-08
- Conditions
- Repetitive Transcranial Magnetic Stimulation, Chronic Visceral Pain, Functional Magnetic Resonance Imaging, IBS (Irritable Bowel Syndrome), Clinical Efficacy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 25 Jan 2026 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: To identify a central hub of visceral pain in IBS-D and elucidate the mechanism by which repetitive transcranial magnetic stimulation (rTMS) confers analgesic effects.
Methods: A total of 42 IBS-D patients were recruited and randomly assigned (1:1) to the sham rTMS or the rTMS group. A nested cohort of 21 IBS-D participants who completed baseline fMRI assessments prior to randomization was included. Consistent with the randomization procedure，these individuals were evenly distributed between the two groups. Both participants and outcome assessors remained blinded to treatment allocation throughout the study. All patients completed the two-week intervention and were included in the final analysis.
Detailed description
Background：Chronic visceral pain in irritable bowel syndrome with diarrhea (IBS-D) is a profound therapeutic challenge. While aberrant central processing is implicated, the key brain regions driving this visceral pain and their suitability as neuromodulatory targets remain undefined.
Methods: Participants were randomly assigned (1:1) to the sham rTMS or rTMS group using a computer-generated randomization sequence created by an independent researcher who was not involved in recruitment, treatment, or outcome assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only after baseline evaluations were completed.
Both participants and outcome assessors were blinded to treatment allocation. The rTMS operators were not involved in data collection or analysis. For the sham condition, the coil was positioned identically over the mPFC with magnetic output disabled, and prerecorded clicking sounds were delivered to mimic the acoustic sensation of stimulation. Participants were asked not to discuss treatment sensations with assessors. Scale raters and fMRI analysts remained blinded until all analyses were finalized.
For the nested fMRI cohort, randomization and blinding procedures were identical, with group allocation revealed only after preprocessing and statistical analysis had been completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham rTMS Group | Sham comparator | Device: Sham (No Treatment)For the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. |
| rTMS Group | Active comparator | Device: Repetitive Transcranial Magnetic StimulationLow-frequency rTMS (1 Hz) was applied to the mPFC using a TMS stimulator at 80% resting motion threshold intensity. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationA figure-of-eight coil is used to apply active low-frequency (1 Hz) rTMS to the corresponding representation area of theprefrontal cortex (mPFC). The treatment is administered for 20 minutes daily for a total of 2 weeks. | Device | rTMS Group |
| Sham (No Treatment)For the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group. | Device | Sham rTMS Group |
Primary outcome
Visceral Sensitivity Index
Time frame: 2 weeks of treatment
(1) Clinical control: After the course of treatment, clinical symptoms disappear; (2) Significant effect: After the course of treatment, the symptom grading is reduced by 2 levels; (3) Effective: After the course of treatment, the symptom grading is reduced by 1 level; (4) Ineffective: After treatment, those who do not meet the above standards.
1 secondary outcome
IBS-symptom severity score
Time frame: 2 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No. This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rui Li, Dr. principal investigator
The First Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Repetitive Transcranial Magnetic Stimulation and Chronic Visceral Pain, run by The First Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruixia Weng, Dr. (15206214921, wengruixia@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral Sensitivity Index (time frame: 2 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.