Migraine Disorders, BrainNCT06796725
Prospective Exploratory Study on rTMS for Migraine Under the Guidance of MEG
A study testing rTMS and Sibelium in people with Migraine Disorders, Brain and rTMS Stimulation, run by Ruijin Hospital at 1 site in China.
Trial summary
Using magnetoencephalography to locate and regulate targets in migraine patients, repeating transcranial magnetic stimulation to physically regulate targets, and evaluating the safety and effectiveness of this treatment method through headache related scales. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Migraine Disorders, Brain, rTMS Stimulation
- What is being tested?
- rTMS and Sibelium
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Feb 2025to 30 Jun 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Complies with specific disease diagnosis: A. Headaches that meet the criteria of B and C (headaches that meet the characteristics of tension headaches or migraines) should occur at least 15 days per month and last for at least 3 months; B. Headaches that meet the criteria of 1.1 migraine without aura diagnosis B-D or 1.2 migraine with aura B and C occurring at least 5 times; C. Headache meets any of the following criteria and occurs for more than 8 days per month, lasting for more than 3 months: ①1.1 C and D of migraine without aura②1.2 B and C of migraine with aura③ The migraine attack perceived by the patient can be relieved by taking triptan or ergot, which cannot be better explained by other diagnoses in ICHD-3.
- Must be able to swallow tablets
- Signed and dated informed consent form Promise to comply with research procedures and cooperate in implementing the entire research process
Who cannot join
- Age under 15 years old; Accompanied by optic disc edema, focal symptoms and signs of the nervous system (except for typical visual and sensory precursors) or cognitive impairment; Sudden and rapidly peaking severe headaches (thunderous headaches)
- Accompanied by fever; New onset headaches in adults, especially after the age of 50; Headaches in patients with high coagulation risk
- New headache in patients with tumor or AIDS history; Headaches related to changes in body position;
- History of epileptic seizures
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
Ruijin Hospital
Shanghai
Xiaodan Wang, Ph.D., +86-21-64370045, wxd12466@rjh.com.cn
About this study
Using magnetoencephalography to locate and regulate targets in migraine patients, repeating transcranial magnetic stimulation to physically regulate targets, and evaluating the safety and effectiveness of this treatment method through headache related scales. Using whole genome data and scale scores for correlation analysis, and conducting randomized controls with traditional drugs to explore new approaches for migraine.
Read the detailed description
Migraine patients who meet the inclusion criteria will be randomly divided into two groups: the MEG+rTMS treatment group and the Sibelium treatment group. Evaluate the clinical efficacy (frequency of attacks (times/month), severity (visual analog scale), duration (d), analgesic drug use rate, and related scale scores) of the MEG+rTMS treatment group and the Sibelium treatment group, respectively. Evaluate its efficacy based on follow-up results and analyze the correlation between different genotypes and efficacy.
- Conditions
- Migraine Disorders, Brain, rTMS Stimulation
- Being tested
- rTMS, Sibelium
- Keywords
- Migraine, MEG, rTMS, RCT
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
(1) The patient undergoes pseudo stimulus intervention in the first week and real stimulus intervention afterwards, which is blind to the patient. (2) Starting from the second week, true stimulation intervention will be conducted for 4 weeks, with each patient making an appointment for 1 month. On Day 7 after the patient intervention, Day 14, Day 30, Day 60, Day 90, Day 180 scales were used to evaluate follow-up.
SibeliumDrug
Sibelium 10mg is taken orally every night for 4 weeks each course of treatment. Patients were evaluated and followed up with a scale based on medication intervention, including Day 7, Day 14, Day 30, Day 60, Day 90, and Day 180
| Study group | Role | What they receive |
|---|---|---|
| RTMS intervention group | Experimental | (1) The patient undergoes pseudo stimulus intervention in the first week and real stimulus intervention afterwards, which is blind to the patient. (2) Starting from the second week, true stimulation intervention will be conducted for 4 weeks, with each patient making an appointment for 1 month. Receives: Device: rTMS |
| Sibelium treatment group | Other | Patients were evaluated and followed up with a scale based on medication intervention. Receives: Drug: Sibelium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache Scale Reduction Rate
Deduction rate=(score of therapeutic efficacy scale at different time points after treatment - score of therapeutic efficacy scale before treatment)/score of therapeutic efficacy scale before treatment. If the headache scale score decreases by 20%, it is considered effective. Follow up evaluations will be conducted on the 7th, 14th, 30th, 60th, 90th, and 180th day after intervention.
Measured: From enrolment to the end of the 4-week treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start6 Feb 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Migraine Disorders, BrainStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796725
- Sponsor's protocol ID
- Migraine-MEG-2024
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing research data requires hospital authorization and consent.
Publications
Teo WP, Kannan A, Loh PK, Chew E, Sharma VK, Chan YC. Poor Tolerance of Motor Cortex rTMS in Chronic Migraine. J Clin Diagn Res. 2014 Sep;8(9):MM01-2. doi: 10.7860/JCDR/2014/9377.4886. Epub 2014 Sep 20.
PubMed 25386478Kalita J, Kumar S, Singh VK, Misra UK. A Randomized Controlled Trial of High Rate rTMS Versus rTMS and Amitriptyline in Chronic Migraine. Pain Physician. 2021 Sep;24(6):E733-E741.
PubMed 34554691
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Exploratory Study on rTMS for Migraine Under the Guidance of MEG
- ClinicalTrials.gov ID
- NCT06796725
- Acronym / sponsor ID
- Migraine-MEG-2024
- Conditions
- Migraine Disorders, Brain, rTMS Stimulation
- Keywords
- Migraine, MEG, rTMS, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 28 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.
Using magnetoencephalography to locate and regulate targets in migraine patients, repeating transcranial magnetic stimulation to physically regulate targets, and evaluating the safety and effectiveness of this treatment method through headache related scales. Using whole genome data and scale scores for correlation analysis, and conducting randomized controls with traditional drugs to explore new approaches for migraine.
Detailed description
Migraine patients who meet the inclusion criteria will be randomly divided into two groups: the MEG+rTMS treatment group and the Sibelium treatment group. Evaluate the clinical efficacy (frequency of attacks (times/month), severity (visual analog scale), duration (d), analgesic drug use rate, and related scale scores) of the MEG+rTMS treatment group and the Sibelium treatment group, respectively. Evaluate its efficacy based on follow-up results and analyze the correlation between different genotypes and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTMS intervention group | Experimental | Device: rTMS(1) The patient undergoes pseudo stimulus intervention in the first week and real stimulus intervention afterwards, which is blind to the patient. (2) Starting from the second week, true stimulation intervention will be conducted for 4 weeks, with each patient making an appointment for 1 month. |
| Sibelium treatment group | Other | Drug: SibeliumPatients were evaluated and followed up with a scale based on medication intervention. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Complies with specific disease diagnosis: A. Headaches that meet the criteria of B and C (headaches that meet the characteristics of tension headaches or migraines) should occur at least 15 days per month and last for at least 3 months; B. Headaches that meet the criteria of 1.1 migraine without aura diagnosis B-D or 1.2 migraine with aura B and C occurring at least 5 times; C. Headache meets any of the following criteria and occurs for more than 8 days per month, lasting for more than 3 months: ①1.1 C and D of migraine without aura②1.2 B and C of migraine with aura③ The migraine attack perceived by the patient can be relieved by taking triptan or ergot, which cannot be better explained by other diagnoses in ICHD-3.
- Must be able to swallow tablets
- Signed and dated informed consent form Promise to comply with research procedures and cooperate in implementing the entire research process
Key exclusion criteria (4 listed)
- Age under 15 years old; Accompanied by optic disc edema, focal symptoms and signs of the nervous system (except for typical visual and sensory precursors) or cognitive impairment; Sudden and rapidly peaking severe headaches (thunderous headaches)
- Accompanied by fever; New onset headaches in adults, especially after the age of 50; Headaches in patients with high coagulation risk
- New headache in patients with tumor or AIDS history; Headaches related to changes in body position;
- History of epileptic seizures
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(1) The patient undergoes pseudo stimulus intervention in the first week and real stimulus intervention afterwards, which is blind to the patient. (2) Starting from the second week, true stimulation intervention will be conducted for 4 weeks, with each patient making an appointment for 1 month. On Day 7 after the patient intervention, Day 14, Day 30, Day 60, Day 90, Day 180 scales were used to evaluate follow-up. | Device | RTMS intervention group |
| SibeliumSibelium 10mg is taken orally every night for 4 weeks each course of treatment. Patients were evaluated and followed up with a scale based on medication intervention, including Day 7, Day 14, Day 30, Day 60, Day 90, and Day 180 | Drug | Sibelium treatment group |
Primary outcome
Headache Scale Reduction Rate
Time frame: From enrolment to the end of the 4-week treatment.
Deduction rate=(score of therapeutic efficacy scale at different time points after treatment - score of therapeutic efficacy scale before treatment)/score of therapeutic efficacy scale before treatment. If the headache scale score decreases by 20%, it is considered effective. Follow up evaluations will be conducted on the 7th, 14th, 30th, 60th, 90th, and 180th day after intervention.
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 11 Feb 2025.
- Results publication: PubMed 25386478Teo WP, Kannan A, Loh PK, Chew E, Sharma VK, Chan YC. Poor Tolerance of Motor Cortex rTMS in Chronic Migraine. J Clin Diagn Res. 2014 Sep;8(9):MM01-2. doi: 10.7860/JCDR/2014/9377.4886. Epub 2014 Sep 20.
- Results publication: PubMed 34554691Kalita J, Kumar S, Singh VK, Misra UK. A Randomized Controlled Trial of High Rate rTMS Versus rTMS and Amitriptyline in Chronic Migraine. Pain Physician. 2021 Sep;24(6):E733-E741.
- Individual participant dataSharing planned: Undecided. Sharing research data requires hospital authorization and consent.
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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.
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 and Sibelium in people with Migraine Disorders, Brain and rTMS Stimulation, run by Ruijin Hospital 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 11 Feb 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. 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 Xiaodan Wang, Doctor (+86-21-64370045, wxd12466@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache Scale Reduction Rate (time frame: From enrolment to the end of the 4-week treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06796725, which also lists 2 linked publications.
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 11 Feb 2025.