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

NCT06796725 | Recruiting DMC

• 1 other identifier: Migraine-MEG-2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine Disorders, Brain; rTMS Stimulation

Keywords

Migraine; MEG; rTMS; RCT

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrolment to the end of the 4-week treatment.

Study Arms (2)

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.

Device: rTMS

Sibelium treatment group

OTHER

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

Drug: Sibelium

Interventions

rTMS 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.

RTMS intervention group

Sibelium 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

Sibelium treatment group

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 25386478 RESULT

• 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.

  PMID: 34554691 RESULT

MeSH Terms

Conditions

Migraine Disorders

Interventions

Flunarizine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Xiaodan Wang, Doctor

CONTACT

+86-21-64370045; wxd12466@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study adopted a single blind approach, with evaluators being blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-01

Locations

CN (1)