Irritable Bowel SyndromerTMSNCT06409078
Repetitive Transcranial Magnetic Stimulation Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea
A study testing rTMS group in people with Irritable Bowel Syndrome and Repetitive Transcranial Magnetic Stimulation, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
Objective: 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome, Repetitive Transcranial Magnetic Stimulation, Chronic Visceral Pain
- What is being tested?
- rTMS group
- 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 Apr 2024to 19 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Inclusion criteria:1.Aged between 18 and 75 years (either sex); 2.A diagnosis of IBS-D according to the Rome IV criteria;3.Experience of Bristol stool type 6 or 7 on at least 4 days per week, with a mean abdominal pain score of ≥3 (on a 0-10 scale) during the 2-week screening period.
Exclusion criteria: 1.Inflammatory or organic gastrointestinal diseases; 2.Diabetes mellitus or hyperthyroidism; 3.History of previous anorectal, intestinal, or abdominal surgery; 4.Current use of medications known to alter gastrointestinal motility or secretion; 5.Pregnancy or lactation; 6.Metallic implants or presence of a cardiac pacemaker; 7.Noncompliance with randomized treatment allocation or demonstrated poor adherence to treatment protocols.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
About this study
Official title: Clinical Study of Repeated Transcranial Magnetic Stimulation (rTMS) for Chronic Visceral Pain in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
Objective: 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.
Design: Combined functional magnetic resonance imaging (fMRI) with visceral sensitivity assessments were used to pinpoint hyperactive brain regions of IBS-D patients. Therefore, a clinical trial was performed to validate the therapeutic potential of rTMS in IBS-D patients.
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
- Irritable Bowel Syndrome, Repetitive Transcranial Magnetic Stimulation, Chronic Visceral Pain, Functional Magnetic Resonance Imaging
- Being tested
- rTMS group, Sham device
- 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.
rTMS groupDevice
Also called transcranial magnetic stimulation
Patients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.
Sham deviceDevice
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 |
|---|---|---|
| repeated transcranial magnetic stimulation group | Active comparator | The rTMS group was given 1 Hz/s for 20 min for 2 week. Receives: Device: rTMS group |
| sham repetitive transcranial magnetic stimulation 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 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 abdominal 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: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.
Secondary outcomes (1)
anorectal manometry
Anorectal manometry was performed on the subjects before and after treatment and the subjects' rectal primary sensory thresholds were recorded. Rectal initial sensory thresholds between 20-90ml were considered normal , less than 20ml was considered as sensitivity rectal sensory, and cure meant that the IBS patients had their rectal initial sensory recordings restored to between 20-90ml.
Measured: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 4 and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 Apr 2024
- Primary completion19 Nov 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies 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 (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Soochow University
- Responsible party
- Principal investigator, Rui Li, The First Affiliated Hospital of Soochow University
- Investigators
- Rui Li, Dr., Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409078
- Sponsor's protocol ID
- 2024156
- Other IDs
- BE2023710, 82470573
- Acronym
- rTMS
- Status last verified
- Nov 2025
- First submitted
- 7 May 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Repeated Transcranial Magnetic Stimulation (rTMS) for Chronic Visceral Pain in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)
- ClinicalTrials.gov ID
- NCT06409078
- Acronym / sponsor ID
- rTMS / 2024156
- Conditions
- Irritable Bowel Syndrome, Repetitive Transcranial Magnetic Stimulation, Chronic Visceral Pain, Functional Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- Soochow University
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 10 May 2024 (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.
Objective: 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.
Design: Combined functional magnetic resonance imaging (fMRI) with visceral sensitivity assessments were used to pinpoint hyperactive brain regions of IBS-D patients. Therefore, a clinical trial was performed to validate the therapeutic potential of rTMS in IBS-D patients.
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 |
|---|---|---|
| repeated transcranial magnetic stimulation group | Active comparator | Device: rTMS groupThe rTMS group was given 1 Hz/s for 20 min for 2 week. |
| sham repetitive transcranial magnetic stimulation group | Sham comparator | Device: Sham deviceFor 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. |
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 |
|---|---|---|
| rTMS groupAlso: transcranial magnetic stimulationPatients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week. | Device | repeated transcranial magnetic stimulation group |
| Sham deviceFor 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 repetitive transcranial magnetic stimulation group |
Primary outcome
IBS-symptom severity score
Time frame: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.
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 abdominal 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.
1 secondary outcome
anorectal manometry
Time frame: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 4 and 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 rTMS group in people with Irritable Bowel Syndrome and Repetitive Transcranial Magnetic Stimulation, 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: finished, as of the sponsor's last update on 25 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS-symptom severity score (time frame: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.). 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 25 Nov 2025.