Actively Recruiting
Double-blind, Randomized Study of Closed-loop Repetitive Transcranial Magnetic Stimulation 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 common and disabling headache condition characterized by moderate to severe headaches lasting from 4 to 72 hours, often accompanied by nausea, vomiting, and sensitivity to sound and light. Researchers are studying repetitive transcranial magnetic stimulation (rTMS), a safe and noninvasive technique, to see if it can help prevent migraines in the short term. This study aims to provide reliable data on the short-term effects of rTMS on migraine prevention, following guidelines for controlled migraine treatment trials but focusing on a shorter study duration of about four weeks of baseline, treatment, and follow-up. The study uses Brightmind.AI's rTMS protocol, applying three rTMS sessions within a 10-day period after determining each participant's motor hotspot and motor threshold. The treatment is compared against a sham control in a double-blind, randomized design. Participants undergo a baseline period of four weeks to record migraine days, followed by the rTMS treatment sessions, and then a four-week follow-up to assess changes in migraine frequency. Participants will keep a migraine diary to track migraine days and differentiate migraine headaches from other types. Researchers will assess monthly migraine days before and after rTMS to measure treatment effect. Safety and adherence will be monitored throughout the study period. Total participation includes a baseline phase, treatment phase, and follow-up, lasting approximately ten weeks in total.
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
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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
G
Gregor Kowarik, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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