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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Migraine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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rTMS group

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

The subjects will receive 20 trains of 100 stimuli each delivered at 10 Hz and 80% of MT over the left MC (M1), 3 days a week, for 4 weeks.

Interventions

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rTMS

The subjects will receive 20 trains of 100 stimuli each delivered at 10 Hz and 80% of MT over the left MC (M1), 3 days a week, for 4 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No