Actively Recruiting
Double-blind, Randomized, Sham-controlled 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
4 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 disorder characterized by moderate to severe headaches lasting 4 to 72 hours, often accompanied by nausea, vomiting, and sensitivity to sound and light. Researchers are evaluating the short-term effects of repetitive transcranial magnetic stimulation (rTMS), a noninvasive and considered safe technique, for preventing migraines. This study aims to provide reliable data on rTMS use following guidelines for controlled migraine treatment trials, focusing on a brief treatment and follow-up period. Participants will be randomly assigned to receive either active rTMS treatment or a sham treatment as a control. The treatment involves three sessions of rTMS within 10 days, using Brightmind.AI's rTMS protocol, after a four-week baseline period. This is followed by a four-week follow-up to evaluate the short-term effects of the treatment on migraine prevention. During the study, participants will monitor their migraine days using a diary and attend study visits for assessments. Researchers will measure the number of monthly migraine days before and after treatment, along with other outcomes such as headache severity, duration, use of acute medication, and responder rates. The study includes safety monitoring and requires adherence to medication and treatment protocols over the entire study period, lasting approximately 8 weeks in total.
CONDITIONS
Brief Title
Closed-loop RTMS for Short-term Migraine Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 to 65 years
- Diagnosis of migraine without aura, migraine with aura, or chronic migraine per ICHD-3 criteria
- Migraine onset before 50 years of age
- At least 4 migraine days in each of the last three 4-week periods before screening
- At least 4 migraine days during one month baseline prior to treatment
- Ability to distinguish migraine headaches from other headache types
- Willingness to follow rTMS regimen and monitor migraine diary
- No medication changes in the 3 months before treatment (6 months for certain medications)
- Stable single migraine prophylaxis drug dose for 3 months before and during study
- No use of other stimulation techniques
- No changes in acupuncture, relaxation, biofeedback, or psychological therapies 3 months prior and during study
- Ability to read and understand study information and complete diaries
- Completed baseline headache diary with no more than 5 missing days
You will not qualify if you...
- More than 26 headache days in any of the last three months before screening
- More than 26 headache days during baseline
- Pregnancy
- Use of Onabotulinumtoxin A for chronic migraine management
- Medication overuse per ICHD-3
- Presence of metals or implanted devices near the head or neck affected by magnetic fields (e.g., stents, stimulators, cochlear implants, bullet fragments)
- Presence of heart pacemakers, defibrillators, intracardiac lines, or medication pumps
- History of severe adverse reactions to rTMS
- Diagnosis of bipolar disorder, substance use disorders, or psychosis
- History or family history of seizures
- Chronic sleep deprivation
- Structural central nervous system disorders (brain tumor, stroke, traumatic brain injury)
- Chronic tinnitus judged by investigator
- Other disorders interfering with the study per investigator
- Participation in other investigational drug or intervention studies until study end
- Botulinum toxin cosmetic use at forehead within 6 months prior to inclusion
- Other clinically relevant pain syndromes
- Depression or anxiety as assessed by specified scales
- Severe health risks including recent malignancy except certain skin or cervical cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants receive repeated transcranial magnetic stimulation treatment or sham treatment using the Brightmind.AI's rTMS device to prevent migraines.
Multiple visits for rTMS treatment sessions
Duration - 4 weeks
Participants are monitored to assess migraine frequency and severity after the rTMS treatment period.
Weekly visits for migraine assessment
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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