rTMS for the Prevention Treatment of CM: a Single Arm Study

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Chronic Migraine

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT03568617

rTMSCM-PUMCH

Details and patient eligibility

About

We design this pilot, single arm study to explore the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic migraine. The hypothetical control group is pooled sham group in latest meta-analysis. We expect a significant improvement of the outcome measures during and after the treatment as compared to the hypothetical control group.

Full description

After a 28-day prospective baseline period using a headache diary to record headache symptoms and any abortive medications used, subjects who meet diagnostic criteria for chronic migraine and don't meet the exclusion criteria will receive rTMS for 4 weeks. The outcome measure will be evaluated at 4 weeks. During the whole trial period, any adverse events are requested to be recorded in the headache diary for analyses. The primary outcome is 50% reduction in the number of days with headache. 50% reduction as assessed by migraine days, moderate/severe headache days, the mean VRS, and conversion to episodic migraine, SGIC, the change from baseline HALT-28, HIT-6, and MSQ v2.1, are used as secondary outcome measures for exploring other benefits associated with treatment.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects meeting the diagnostic criteria for chronic migraine according to the International Classification of Headache Disorders, 3rd edition.
• The duration of chronic migraine ≥ 6 months.
• age range of 18 - 65 years old

Exclusion criteria

• Secondary headaches except MOH
• any change of the prophylaxis or the analgesic drug strategy during the baseline and follow-up period
• structural brain lesions
• seizures
• severe systemic disease
• TMS contraindications (such as metal implants)
• psychosis
• severe depression or anxiety
• drug or alcohol dependence
• pregnancy
• participating in other experiments at the same time

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

rTMS group

Experimental group

Treatment:

Device: rTMS