Machine learning test for diagnosing migraines
Pilot Study for Machine Learning as Applied to EEG as an Aid to the Diagnosis of Adult Migraineurs Without Aura, or Migraineurs With Aura on Interictal (Non-pain) Days
This study is testing if a new machine learning tool using brain signals can help doctors accurately diagnose migraines in adults aged 18 to 70.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Headache Sciences Incorporated Industry-sponsored |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05517200 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and efficacy of electrical biomarkers obtained through EEG to confirm migraine diagnoses in adults aged 18 to 70. Participants who meet the International Classification of Headache Disorders criteria will be selected randomly, and the data analyst will be blinded to patient identifiers. The study hypothesizes that machine learning can differentiate between migraine patients with and without aura and normal controls based on specific brain signals. The approach combines advanced EEG technology with machine learning software to enhance diagnostic accuracy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 70 who have been diagnosed with migraines and can provide reliable responses to questionnaires.
Not a fit: Patients under 18 or over 70 years old, as well as those unable to comply with study requirements, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more accurate and objective method for diagnosing migraines.
How similar studies have performed: While the use of machine learning in headache diagnosis is a novel approach, similar studies have shown promise in utilizing EEG for neurological conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ● Age range: All participants and controls will be adults over 18, and no greater than 70 * Sex: Migraine patients and controls to reflect the demographics of the disease such that there is a balanced mix of males to females that reflects known female to male ratio for migraine is 3 to 1. * Capable of giving clear and reliable answers on the questionnaires * All potential participants should be able to read, write and speak in English: unless they can bring a translator. * All mentally competent: to give accurate answers on questionnaires, to decide for themselves and sign the informed consent form. * All medically stable patients. * Capable of safely using a staircase to our downstairs lab * OHIP must be up-to-date and participants must show a valid OHIP number * Able and willing to comply with all study requirements * Normal controls must be very healthy. Exclusion Criteria: * ● Under 18 years old * Over 70 years old (71 and above) * Incompetent in english language and no translator (This applies to reading, writing and speaking.) * Current moderate or serious mental illness (including depression, anxiety disorder, psychosis) * Mentally disabled/ Mentally incompetentHistory of photo-epilepsy or history of seizure following shortly after visual stimulus such as bright or repetitive flashes of light, repetitive flashes of light (such as at a disco, or looking at an overhead fan), or after looking at repetitive visual patterns lines such as looking at multiple stripes or squares, or from seeing movement such as when watching an action movie. * Medically unstable * Prisoner * Unable to go down the stairs (if recording is downstairs) * Pacemaker * Defibrillator * Cochlear implants * Significant skull deformity (e.g. a depression of greater than half an inch * Head injury with consciousness loss in the last year, even with apparent full recovery. * Severe facial trauma within the last three months, or longer if unrecovered. * Unnatural material inside the head or mouth based on history (including clips from surgery, shrapnel, bullet, medical pump, wires, medical device, metal dental implants) * Chronic communicable diseases carried (including Hepatitis B, Hepatitis C, HIV, Creutzfeldt-Jakob Disease) Note: Vagal stimulator and insulin pump are not an exclusion criteria, but must be turned off before the EEG recording starts. 4.2.2 EXCLUSION CRITERIA FOR NORMAL CONTROLS * not in excellent physical health * not in excellent neurological health and especially, no headache disorder at all in the last three months * not in excellent mental health * no central sensitization disorder (For details see section for "Central Sensitization Questionnaires" in the document called "General Headache Registration and History Form For Migraine With Aura, Migraine Without Aura and Normal Controls and Frequent Tension-Type Headache Controls". (See documents provided to Veritas IRB via Concierge.) * not a good sleeper * no chronic pain disorder * No psychoactive drugs for 2 weeks before recording day * Not currently in pain on recording day * No neurological illness * No known moderate to severe mental illness 4.2.3 EXCLUSION CRITERIA FOR MIGRAINE WITH AURA: * Chronic migraine with aura 4.2.3 EXCLUSION CRITERIA FOR MIGRAINE WITHOUT AURA: ● Chronic migraine without aura 4.2.4 EXCLUSION CRITERIA FOR TENSION-TYPE HEADACHES: * A history of migraine (including any presently suspected to have recent migraine) * Chronic tension-type headache
Where this trial is running
Toronto, Ontario
- Headache Sciences Incorporated Laboratory — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Mark S. Doidge, MD, BA
- Email: headachesciences@gmail.com
- Phone: 6472072504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.