Prospective Exploratory Study on rTMS for Migraine Under the Guidance of MEG
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS, Sibelium.
- Who it may be relevant to
- Registry conditions: Migraine Disorders, Brain, rTMS Stimulation. Basic parameters: 15 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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. On Day 7 after the patient intervention, Day 14, Day 30, Day 60, Day 90, Day 180 scales were used to evaluate follow-up. - Drug 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
Primary outcome measures
- Headache Scale Reduction Rate [Time frame: From enrolment to the end of the 4-week treatment.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital — Shanghai
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. PMID 25386478
- 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
Identifiers
NCT: NCT06796725 · Migraine-MEG-2024