Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
20 participants
OBSERVATIONAL
2022-09-03
2025-06-30
Brief Summary
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The proposed study is intended to establish safety and efficacy of quantifiable electrical biomarkers for migraine that can be used to confirm a diagnosis in people that have already been screened as positive for migraine using the gold standard participative criteria set out in the International Classification of Headache disorders-3 (ICHD-3) criteria.
It is hypothesized that specific brain signals can be used to distinguish between migraine patients with and without aura from normal control and tension- type headache control participants by EEG enhanced with machine learning software.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Normal Control
These participants are normal control in good mental and psychiatric health.
Machine Learning Test for Migraine
Resting EEG, and Visual and Auditory Stimulation
Migraine
These participants have migraines according to ICHD-3 criteria.
Machine Learning Test for Migraine
Resting EEG, and Visual and Auditory Stimulation
Interventions
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Machine Learning Test for Migraine
Resting EEG, and Visual and Auditory Stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
* 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
* Chronic migraine with aura
● Chronic migraine without aura
* A history of migraine (including any presently suspected to have recent migraine)
* Chronic tension-type headache
18 Years
70 Years
ALL
Yes
Sponsors
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Headache Sciences Incorporated
INDUSTRY
Responsible Party
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Locations
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Headache Sciences Incorporated Laboratory
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Related Links
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United States ( 12 ) Patent Application Publication Pub . No . : US 2018 / 0242919 A1 DOIDGE et al . ( 43 ) Pub . Date : Aug . 30 , 2018 ( 54 ) DIAGNOSIS OF MIGRAINE VIA EXPERT SYSTEM
Other Identifiers
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MLTM1
Identifier Type: -
Identifier Source: org_study_id
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