Closed-loop RTMS for Short-term Migraine Prevention

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrightmind.AI

About this trial

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.

Eligibility criteria

Qualifiers

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

Male or female, aged 18-65

Migraine without aura, migraine with aura or chronic migraine according to the diagnostic criteria of the third edition of the International Classification of Headache Disorders (ICHD-3) - Age of onset before 50 years of age

Disqualifiers

More than 26 headache days in any of three subsequent months preceding the screening visit.

More than 26 headache days during baseline

Pregnant persons

Usage of Onabotulinumtoxin A for managing chronic migraines.

Trial design

Treatments tested in this trial

  • rTMS treatment
  • Determination of motor hotspot and motor treshold

Treatment groups

88 Participants
are divided into 2 treatment groups

Locations

1
Univ.-Klinik für Neurologie, Medizinische Universität Wien1010, ViennaState of Vienna, Austria

Sponsors and collaborators

Brightmind.AI

Lead sponsor

Medical University of Vienna

Collaborator