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

NCT ID: NCT06796725

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-06
• Study Completion Date: 2026-06-30

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.

Conditions

Migraine Disorders, Brain; rTMS Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

RTMS intervention group

(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.

Group Type: EXPERIMENTAL

rTMS

Intervention Type: DEVICE

(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.

Sibelium treatment group

Patients were evaluated and followed up with a scale based on medication intervention.

Group Type: OTHER

Sibelium

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DEVICE

Sibelium

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaodan Wang, Doctor

Role: CONTACT

wxd12466@rjh.com.cn

+86-21-64370045

Facility Contacts

Xiaodan Wang, Ph.D.

Role: primary

wxd12466@rjh.com.cn

+86-21-64370045

References

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.

Reference Type: RESULT

PMID: 25386478 (View on PubMed)

Kalita 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.

Reference Type: RESULT

PMID: 34554691 (View on PubMed)

Other Identifiers

Migraine-MEG-2024

Identifier Type: -

Identifier Source: org_study_id