Poor Tolerance of Motor Cortex rTMS in Chronic Migraine.
Wei-Peng Teo, Aravinda Kannan, Pei-Kee Loh...
https://pubmed.ncbi.nlm.nih.gov/25386478Actively Recruiting
Phase Not Applicable
Age: 15Years - 50Years
All Genders
ID06796725
Prospective Exploratory Study on Repetitive Transcranial Magnetic Stimulation (rTMS) for Migraine Guided by Magnetoencephalography (MEG)
Led by Ruijin Hospital · Updated on 2025-02-11
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to explore new treatments for migraine by using magnetoencephalography (MEG) to locate brain targets and applying repetitive transcranial magnetic stimulation (rTMS) to regulate these areas. The study compares the safety and effectiveness of rTMS combined with MEG guidance against the traditional migraine drug Sibelium. It also investigates how different genetic profiles may relate to treatment outcomes. Participants will be randomly assigned to one of two groups: the MEG+rTMS treatment group or the Sibelium treatment group. The rTMS group first receives a week of placebo-like stimulation followed by four weeks of real stimulation, with sessions scheduled over one month. The Sibelium group takes 10 mg of the medication orally every night for four weeks. Both groups are followed up with evaluations using headache and related scale scores at multiple time points. During the study, participants will be assessed on headache frequency, severity, duration, medication use, and other related scales at days 7, 14, 30, 60, 90, and 180. The primary outcome is the reduction rate in headache scale scores from enrollment to the end of the four-week treatment. Participants are monitored for safety and treatment effects throughout the study, which runs until June 2026.
CONDITIONS
Brief Title
Prospective Exploratory Study on rTMS for Migraine Under the Guidance of MEG
Who Can Participate
Age: 15Years - 50Years
All Genders
Eligibility Criteria
You may qualify if you...
- Headaches occurring at least 15 days per month for at least 3 months
- Diagnosis of migraine without aura or with aura meeting specific criteria, with at least 5 attacks
- Headaches lasting more than 8 days per month for over 3 months, relieved by triptan or ergot, and not explained by other diagnoses
- Ability to swallow tablets
- Signed informed consent and willingness to comply with study procedures
You will not qualify if you...
- Under 15 years old
- Presence of optic disc edema, focal neurological symptoms (except typical visual or sensory symptoms), or cognitive impairment
- Sudden, severe headache onset (thunderclap headaches)
- Fever accompanying headache
- New onset headaches especially after age 50
- High coagulation risk
- History of tumors, AIDS, or epileptic seizures
- Headaches related to changes in body position
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 5 weeks per treatment course
Participants receive either rTMS device therapy or oral Sibelium medication for migraine, with specific schedules for each intervention group.
1 visit during the first week for pseudo stimulus, followed by 4 weeks of treatment; medication taken daily for 4 weeks
Follow-up
Duration - Up to 6 months post-treatment
Participants are evaluated with scales at multiple time points to assess treatment efficacy and migraine symptoms.
Visits on Days 7, 14, 30, 60, 90, and 180 after treatment
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, China
Actively Recruiting
Loading map...
Research Team
X
Xiaodan Wang, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
A Randomized Controlled Trial of High Rate rTMS Versus rTMS and Amitriptyline in Chronic Migraine.
Jayantee Kalita, Sumit Kumar, Varun K Singh...
https://pubmed.ncbi.nlm.nih.gov/34554691