Pilot Study for a Machine Learning Test for Migraine (MLTM)

  • End date
    Jun 19, 2024
  • participants needed
  • sponsor
    Headache Sciences Incorporated
Updated on 7 October 2022
Accepts healthy volunteers


This study is a single center, random participant selection, data analyst is blinded to patient identifiers, controlled clinical trial.

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.

Condition Migraine
Treatment Machine Learning Test for Migraine
Clinical Study IdentifierNCT05517200
SponsorHeadache Sciences Incorporated
Last Modified on7 October 2022


Yes No Not Sure

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
Unable to go down the stairs (if recording is downstairs)
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
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
Chronic migraine with aura
● Chronic migraine without aura
A history of migraine (including any presently suspected to have recent migraine)
Chronic tension-type headache
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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