Pilot Study for a Machine Learning Test for Migraine
MLTM
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
1 other identifier
observational
20
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedStudy Start
First participant enrolled
September 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedSeptember 29, 2023
September 1, 2023
2.7 years
August 24, 2022
September 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility of machine learning as applied to EEG to diagnose migraine.
The primary endpoint is a sensitivity of 79% and a specificity of 72% in distinguishing migraine with and without aura screened using the ICHD-3 benchmark criteria as compared to normal controls.
2 years
Study Arms (2)
Normal Control
These participants are normal control in good mental and psychiatric health.
Migraine
These participants have migraines according to ICHD-3 criteria.
Interventions
Resting EEG, and Visual and Auditory Stimulation
Eligibility Criteria
All participants and controls will be adults over 18, and no greater than 70. 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. They are 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. Normal controls must be very healthy.
You may qualify if:
- ● 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.
You may not qualify if:
- ● 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)
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Headache Sciences Incorporated Laboratory
Toronto, Ontario, M4M1G9, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Day
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 26, 2022
Study Start
September 3, 2022
Primary Completion
June 1, 2025
Study Completion
June 1, 2025
Last Updated
September 29, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share