Migraine is a prevalent and debilitating primary headache disorder, where patients suffer from disabling symptoms that usually consist of a moderate to severe headache lasting 4 to 72 hours, nausea and/or vomiting, phonophobia and photophobia. Transcranial magnetic stimulation (TMS) is a noninvasive technique that is considered to be safe. Repetitive TMS (rTMS) might be useful for migraine prophylaxis. However, available studies on the use of rTMS for preventive treatment of migraine are limited. Currently, rTMS is not recommended in the recent guidelines for the treatment of migraine published by the German Neurological Society in 2022. Therefore, the aim of the current study is to provide reliable data on the short-term effect of rTMS for the prevention of migraine. The investigators will follow the Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition, with the exception of study duration, which will be limited to four weeks of baseline, three sessions of rTMS within a 10-day timeframe and 4 weeks of follow-up as our study aims to examine short-term efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
88
Brightmind.AI´s rTMS protocol is applied
Determination of motor hotspot and motor treshold
Univ.-Klinik für Neurologie, Medizinische Universität Wien
Vienna, State of Vienna, Austria
RECRUITINGMonthly migraine days (MMD)
Mean number of MMD 4 weeks before and 4 weeks after rTMS treatment.
Time frame: comparing 4 weeks before with 4 weeks after rTMS
50 percent responder rate
Responder rate as a reduction in MMD by 50 percent or more.
Time frame: comparing 4 weeks before with 4 weeks after rTMS
Weekly Migraine days after stimulation.
Mean
Time frame: comparing 4 weeks before with 4 weeks after rTMS
Monthly headache days
Mean number of monthly headache days before and after rTMS treatment.
Time frame: comparing 4 weeks before with 4 weeks after rTMS
Monthly (4 weeks) days with use of acute medication
Mean number of monthly days with acute medication usage before and after rTMS treatment.
Time frame: comparing 4 weeks before with 4 weeks after rTMS
Headache severity
Mean headache severity of migraine headaches before and after rTMS treatment.
Time frame: comparing 4 weeks before with 4 weeks after rTMS
Duration of migraine attacks
Mean duration of migraine attacks before and after rTMS treatment.
Time frame: comparing 4 weeks before with 4 weeks after rTMS
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