Irritable Bowel Syndrome (IBS)NCT07345377
Study on Treatment Mechanisms and Efficacy Prediction of Individualized Transcranial Magnetic Stimulation in Adults With Irritable Bowel Syndrome Using Multimodal MRI and High-Throughput Sequencing
A study testing Individualized TMS Intervention in people with Irritable Bowel Syndrome (IBS) and Pain, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.
Trial summary
The goal of this clinical trial is to explore if "individualized repetitive Transcranial Magnetic Stimulation (TMS)" works to improve symptoms in adults with Irritable Bowel Syndrome (IBS). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS), Pain, Depressive Disorder, Major, Moderate
- What is being tested?
- Individualized TMS Intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Dec 2028
- 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
Who may be able to join
- Meets the Rome IV diagnostic criteria for Irritable Bowel Syndrome (IBS);
- Has discontinued IBS-related medications for more than 2 weeks prior to enrollment;
- Aged between 18 and 75 years (inclusive);
- Has sufficient cognitive ability to provide informed consent, understand study instructions, and complete questionnaires.
Who cannot join
- Has contraindications to MRI (e.g., metal implants in the body, claustrophobia) or TMS (e.g., history of epilepsy, skull defects);
- Diagnosed with mental illnesses (e.g., schizophrenia, bipolar disorder) that require ongoing medication or psychotherapy;
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Presents signs of severe illness requiring hospitalization (e.g., hemodynamic instability, acute infection, acute myocardial infarction, cerebral infarction);
- Has taken any substances that may affect study indicators (e.g., probiotics, prebiotics) within 3 months prior to enrollment.
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
The affiliated hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310015
About this study
Official title: Exploratory Clinical Study to Investigate the Therapeutic Mechanisms, Efficacy Prediction, and Safety Profile of Individualized Transcranial Magnetic Stimulation as a Therapeutic Intervention in Adult Participants Diagnosed With Irritable Bowel Syndrome, Utilizing Multimodal Magnetic Resonance Imaging for Neuroimaging Assessment and High-Throughput Sequencing for Fecal Microbiota Analysis and Metabolic Profile Detection
The goal of this clinical trial is to explore if "individualized repetitive Transcranial Magnetic Stimulation (TMS)" works to improve symptoms in adults with Irritable Bowel Syndrome (IBS). It also aims to learn how this treatment works (by looking at links between the brain, gut, and gut bacteria) and if tests like brain scans or gut bacteria checks can show if the treatment will work for a person. The main questions it aims to answer are:
Will individualized TMS improve IBS symptoms (like stomach pain or discomfort) and affect the links between the brain, gut, and gut bacteria? Can brain scan results (from multimodal Magnetic Resonance Imaging, MRI) and gut bacteria checks (from high-throughput sequencing) predict how well a person responds to TMS?
Read more
Participants will be adults aged 18-59 who:
Meet the Rome Ⅳ criteria for IBS (a standard way to diagnose IBS); Have stopped taking IBS-related medicines for more than 2 weeks; Do NOT have MRI or TMS contraindications (like metal implants in the body, mental illness, pregnancy, or serious illnesses requiring hospital stays).
Participants will:
Receive 10 TMS sessions (5 times a week, for 2 weeks total) - TMS is a non-invasive treatment that uses gentle magnetic pulses on the scalp;
Before the first TMS session, and again after the 10th session:
Fill out surveys to rate IBS symptoms; Have an MRI scan (painless, takes about 60 minutes) to look at brain activity; Provide a small stool sample to check gut bacteria.
- Being tested
- Individualized TMS Intervention, Sham TMS Intervention
- Medical subject headings
- Irritable Bowel Syndrome, Pain, Depressive Disorder, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized TMS InterventionDevice
This individualized transcranial magnetic stimulation (TMS) intervention distinguishes itself from conventional fixed-target TMS by using resting-state fMRI functional connectivity to determine the personalized left dorsolateral prefrontal cortex (DLPFC) target. It uses a Magstim TMS system (infrared optical navigation) for precise positioning. Stimulation intensity is 90% of the individual's resting motor threshold (RMT; MEPs >50μV in ≥5/10 stimulations), delivered via the iTBS paradigm (3 pulses/burst [50Hz], 5Hz burst repetition, 2s stimulation/8s rest, 3 cycles/1800 pulses per session). This personalized targeting design enhances precision, setting it apart from non-individualized TMS in other studies.
Sham TMS InterventionDevice
This sham TMS intervention is designed to maintain double-blinding: it uses the same equipment (Magstim infrared navigation TMS system), procedures (individual RMT measurement, personalized left DLPFC target positioning), iTBS paradigm (3 pulses/burst [50Hz], 5Hz repetition, 2s/8s cycle, 1800 pulses/session) and duration (20min core/40min total per session, 10 total sessions) as the individualized TMS in this study. Its only distinction (from the experimental intervention) is the 90° coil orientation (directing magnetic field away from the scalp, no effective cortical stimulation).
| Study group | Role | What they receive |
|---|---|---|
| Individualized TMS Intervention | Experimental | Participants in this group receive the individualized transcranial magnetic stimulation (TMS) intervention. Receives: Device: Individualized TMS Intervention |
| Sham TMS Intervention | Sham comparator | Participants in this group receive the sham TMS intervention (for blinding purposes). Receives: Device: Sham TMS Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritable Bowel Syndrome Symptom Severity Rating Scale (IBS-SSS)
Assessment of the severity of irritable bowel syndrome symptoms (including abdominal pain, bloating, diarrhea/constipation, and impact on daily life) using the IBS-SSS. Scale Details: Minimum value: 0 points; Maximum value: 500 points; Score interpretation: Higher scores indicate more severe IBS symptoms.
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Secondary outcomes (9)
Fecal microbiota composition
Analysis of the composition and diversity of fecal microbiota (including phylum, genus, and species levels) using high-throughput sequencing of 16S rRNA genes.
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session)
Fecal Metabolic Profile
Detection of fecal metabolic metabolites (including amino acids, short-chain fatty acids, and bile acids) using liquid chromatography-mass spectrometry (LC-MS) based metabolomics.
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session)
Visual Analogue Scale (VAS) for Pain
Assessment of the degree of abdominal pain in participants using a 10-point visual analog scale. Scale Details: Minimum value: 0 points (no pain); Maximum value: 10 points (most severe pain imaginable). Score interpretation: Higher scores indicate more severe abdominal pain.
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Evaluates multi-dimensional characteristics of abdominal pain in participants, including pain intensity (assessed via visual analog scale and numerical rating scale) and pain quality (e.g., stabbing, bloating, cramping). Scale Details:
Minimum value: 0 points; Maximum value: 45 points; Score interpretation: Higher scores indicate more severe and distressing abdominal pain.
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Irritable Bowel Syndrome Quality of Life Scale (IBS-QOL)
Assesses the impact of irritable bowel syndrome on participants' quality of life, covering dimensions such as symptom distress, emotional function, social function, and daily activity limitation. Scale Details: Minimum value: 0 points; Maximum value: 100 points; Score interpretation: Higher scores indicate better quality of life (less impact from IBS symptoms).
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
17 items-Hamilton Depression Rating Scale (HAMD-17)
Assessment of the severity of depressive symptoms in participants using the 17-item Hamilton Depression Rating Scale. Scale Details: Minimum value: 0 points; Maximum value: 54 points; Score interpretation: Higher scores indicate more severe depressive symptoms.
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
14 items-Hamilton Anxiety Rating Scale (HAMA-14)
Assesses the severity of anxiety symptoms in participants, covering both psychological anxiety dimensions (e.g., tension, fear, restlessness) and somatic anxiety dimensions (e.g., palpitations, muscle soreness, gastrointestinal discomfort). Scale Details: Minimum value: 0 points; Maximum value: 56 points; Score interpretation: Higher scores indicate more severe anxiety symptoms.
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Brain Function Features (Multimodal MRI)
Assessment of brain functional indicators covering multiple dimensions of neural activity and circuit organization:
- Spontaneous brain activity: Quantifies the intensity and synchronization of intrinsic resting-state neural activity, including: Amplitude of low-frequency fluctuations (ALFF); Regional Homogeneity (ReHo).
- Functional connectivity: Measures inter-regional neural associations, including: Seed-based correlation analysis; Dynamic Causal Modeling (DCM).
- Brain network organization: Analyzes large-scale circuit integration, including: Independent Component Analysis (ICA); Brain network topology.
The above are representative indicators; other relevant brain functional metrics may be included as needed.
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Brain Structure Features (Multimodal MRI)
Assessment of brain structural indicators including gray matter volume (measured by voxel-based morphometry) and white matter integrity (measured by fractional anisotropy via diffusion tensor imaging).
Measured: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies of the same condition, open and under way.
- 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
- Model description
- This study adopts a parallel group design, with participants randomly assigned to either the individualized TMS intervention group or the sham-TMS control group. The two groups are compared simultaneously to evaluate the efficacy and safety of the intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345377
- Sponsor's protocol ID
- 2024(E2)-HS-009
- Status last verified
- Oct 2025
- First submitted
- 19 Dec 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Clinical Study to Investigate the Therapeutic Mechanisms, Efficacy Prediction, and Safety Profile of Individualized Transcranial Magnetic Stimulation as a Therapeutic Intervention in Adult Participants Diagnosed With Irritable Bowel Syndrome, Utilizing Multimodal Magnetic Resonance Imaging for Neuroimaging Assessment and High-Throughput Sequencing for Fecal Microbiota Analysis and Metabolic Profile Detection
- ClinicalTrials.gov ID
- NCT07345377
- Acronym / sponsor ID
- 2024(E2)-HS-009
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jan 2026 (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.
The goal of this clinical trial is to explore if "individualized repetitive Transcranial Magnetic Stimulation (TMS)" works to improve symptoms in adults with Irritable Bowel Syndrome (IBS). It also aims to learn how this treatment works (by looking at links between the brain, gut, and gut bacteria) and if tests like brain scans or gut bacteria checks can show if the treatment will work for a person. The main questions it aims to answer are:
Will individualized TMS improve IBS symptoms (like stomach pain or discomfort) and affect the links between the brain, gut, and gut bacteria? Can brain scan results (from multimodal Magnetic Resonance Imaging, MRI) and gut bacteria checks (from high-throughput sequencing) predict how well a person responds to TMS?
Participants will be adults aged 18-59 who:
Meet the Rome Ⅳ criteria for IBS (a standard way to diagnose IBS); Have stopped taking IBS-related medicines for more than 2 weeks; Do NOT have MRI or TMS contraindications (like metal implants in the body, mental illness, pregnancy, or serious illnesses requiring hospital stays).
Participants will:
Receive 10 TMS sessions (5 times a week, for 2 weeks total) - TMS is a non-invasive treatment that uses gentle magnetic pulses on the scalp;
Before the first TMS session, and again after the 10th session:
Fill out surveys to rate IBS symptoms; Have an MRI scan (painless, takes about 60 minutes) to look at brain activity; Provide a small stool sample to check gut bacteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study adopts a parallel group design, with participants randomly assigned to either the individualized TMS intervention group or the sham-TMS control group. The two groups are compared simultaneously to evaluate the efficacy and safety of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Individualized TMS Intervention | Experimental | Device: Individualized TMS InterventionParticipants in this group receive the individualized transcranial magnetic stimulation (TMS) intervention. |
| Sham TMS Intervention | Sham comparator | Device: Sham TMS InterventionParticipants in this group receive the sham TMS intervention (for blinding purposes). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets the Rome IV diagnostic criteria for Irritable Bowel Syndrome (IBS);
- Has discontinued IBS-related medications for more than 2 weeks prior to enrollment;
- Aged between 18 and 75 years (inclusive);
- Has sufficient cognitive ability to provide informed consent, understand study instructions, and complete questionnaires.
Key exclusion criteria (5 listed)
- Has contraindications to MRI (e.g., metal implants in the body, claustrophobia) or TMS (e.g., history of epilepsy, skull defects);
- Diagnosed with mental illnesses (e.g., schizophrenia, bipolar disorder) that require ongoing medication or psychotherapy;
- Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
- Presents signs of severe illness requiring hospitalization (e.g., hemodynamic instability, acute infection, acute myocardial infarction, cerebral infarction);
- Has taken any substances that may affect study indicators (e.g., probiotics, prebiotics) within 3 months prior to enrollment.
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 |
|---|---|---|
| Individualized TMS InterventionThis individualized transcranial magnetic stimulation (TMS) intervention distinguishes itself from conventional fixed-target TMS by using resting-state fMRI functional connectivity to determine the personalized left dorsolateral prefrontal cortex (DLPFC) target. It uses a Magstim TMS system (infrared optical navigation) for precise positioning. Stimulation intensity is 90% of the individual's resting motor threshold (RMT; MEPs >50μV in ≥5/10 stimulations), delivered via the iTBS paradigm (3 pulses/burst [50Hz], 5Hz burst repetition, 2s stimulation/8s rest, 3 cycles/1800 pulses per session). This personalized targeting design enhances precision, setting it apart from non-individualized TMS in other studies. | Device | Individualized TMS Intervention |
| Sham TMS InterventionThis sham TMS intervention is designed to maintain double-blinding: it uses the same equipment (Magstim infrared navigation TMS system), procedures (individual RMT measurement, personalized left DLPFC target positioning), iTBS paradigm (3 pulses/burst [50Hz], 5Hz repetition, 2s/8s cycle, 1800 pulses/session) and duration (20min core/40min total per session, 10 total sessions) as the individualized TMS in this study. Its only distinction (from the experimental intervention) is the 90° coil orientation (directing magnetic field away from the scalp, no effective cortical stimulation). | Device | Sham TMS Intervention |
Primary outcome
Irritable Bowel Syndrome Symptom Severity Rating Scale (IBS-SSS)
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Assessment of the severity of irritable bowel syndrome symptoms (including abdominal pain, bloating, diarrhea/constipation, and impact on daily life) using the IBS-SSS. Scale Details: Minimum value: 0 points; Maximum value: 500 points; Score interpretation: Higher scores indicate more severe IBS symptoms.
9 secondary outcomes
Fecal microbiota composition
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session)
Fecal Metabolic Profile
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session)
Visual Analogue Scale (VAS) for Pain
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Irritable Bowel Syndrome Quality of Life Scale (IBS-QOL)
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
17 items-Hamilton Depression Rating Scale (HAMD-17)
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
14 items-Hamilton Anxiety Rating Scale (HAMA-14)
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Brain Function Features (Multimodal MRI)
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
Brain Structure Features (Multimodal MRI)
Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)
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 1 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized TMS Intervention in people with Irritable Bowel Syndrome (IBS) and Pain, run by The Affiliated Hospital of Hangzhou Normal 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?
The sponsor lists 4 inclusion and 5 exclusion criteria. 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: enrolling by invitation, as of the sponsor's last update on 1 Jun 2026. 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?
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?
Irritable Bowel Syndrome Symptom Severity Rating Scale (IBS-SSS) (time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)). 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 1 Jun 2026.