Actively Recruiting
Closed-loop RTMS for Short-term Migraine Prevention
Led by Brightmind.AI · Updated on 2024-12-27
88
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
Sponsors
B
Brightmind.AI
Lead Sponsor
M
Medical University of Vienna
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Closed-loop RTMS for Short-term Migraine Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form provided
- Willing and able to comply with all study procedures and available for the entire study duration
- Male or female aged between 18 and 65 years
- Diagnosed with migraine without aura, migraine with aura, or chronic migraine according to ICHD-3 criteria
- Migraine started before age 50
- At least 4 migraine days in each of three consecutive 4-week periods before screening
- At least 4 migraine days during the one-month baseline before treatment
- Able to distinguish migraine headaches from other headache types
- Willing to follow the rTMS treatment schedule and able to keep a migraine diary
- No changes in medication use or regimen for at least three months before starting treatment (six months for certain migraine medications)
- No changes in medication during the entire study period
- Use of a single migraine prevention drug allowed if dose stable for at least 3 months before and during study
- No other stimulation techniques used
- No changes in acupuncture, relaxation, biofeedback, behavioral or psychotherapeutic treatments for three months before and during the study
- Able to read and understand study materials and complete headache diary with no more than 5 missing days out of 28
You will not qualify if you...
- More than 26 headache days in any of the three months before screening
- More than 26 headache days during baseline
- Pregnant persons
- Use of Onabotulinumtoxin A for chronic migraine management
- Medication overuse headache according to ICHD-3
- Presence of metals or implanted devices affected by magnetic fields near the head or neck, including stents, stimulators, brain implants, cochlear implants, magnetic implants, bullet or grenade fragments
- Presence of pacemakers, defibrillators, intracardiac lines, or medication pumps
- Known severe adverse reactions to rTMS
- Diagnosis of bipolar disorder, substance use disorders, or psychosis
- Known personal or family history of seizures
- Chronic sleep deprivation
- Structural central nervous system disorders such as brain tumor, stroke, or traumatic brain injury
- Chronic tinnitus as judged by investigator
- Other disorders interfering with study participation as judged by investigator
- Treatment with another investigational drug or intervention until study end
- Botulinum toxin injections for cosmetic reasons at forehead within six months before study
- Other clinically relevant pain syndromes
- Depression or anxiety with scores above thresholds on BDI-II or DASS-21 assessments
- Severe health risks including recent malignancies within past 5 years except certain skin or cervical cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Univ.-Klinik für Neurologie, Medizinische Universität Wien
Vienna, State of Vienna, Austria, 1010
Actively Recruiting
Research Team
L
Luca Ticini, PhD
CONTACT
G
Gregor Kowarik, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here