Prospective Exploratory Study on rTMS for Migraine Under the Guidance of MEG

Not Applicable

Recruiting

• Conditions: Migraine Disorders, Brain; rTMS Stimulation
• Interventions: Drug: Sibelium; Device: rTMS

• Registration Number: NCT06796725
• Lead Sponsor: Ruijin Hospital

Brief 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. 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 Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-22
• Study First Posted: 2025-01-28
• Study Start: 2025-02-06
• Last Update Submitted: 2025-02-08
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sibelium treatment group	Sibelium	Patients were evaluated and followed up with a scale based on medication intervention.
RTMS intervention group	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.

Primary Outcome Measures

Name	Time	Method
Headache Scale Reduction Rate	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.

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, China