Closed-loop RTMS for Short-term Migraine Prevention
ConditionMigraine Disorders
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
rTMS treatment
DeviceBrightmind.AI´s rTMS protocol is applied
Determination of motor hotspot and motor treshold
DeviceDetermination of motor hotspot and motor treshold
Treatment groups
88 Participants
are divided into 2 treatment groupsGroup A: Active groupActive comparator 2 interventions
Group B: Sham groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Monthly 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 rTMSSecondary outcomes
1
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 rTMS2
Weekly Migraine days after stimulation.
Mean
Time frame
comparing 4 weeks before with 4 weeks after rTMS3
Monthly headache days
Mean number of monthly headache days before and after rTMS treatment.
Time frame
comparing 4 weeks before with 4 weeks after rTMS4
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 rTMSSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brightmind.AI
Lead sponsor
Medical University of Vienna
Collaborator
Source ClinicalTrials.gov