MigraineMLTMNCT05517200
Pilot Study for a Machine Learning Test for Migraine
An observational study of Migraine and Chronic Migraine, run by Headache Sciences Incorporated at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine, Chronic Migraine, Tension-Type Headache
- What is being tested?
- Machine Learning Test for Migraine
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 3 Sep 2022to Jun 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- ● 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.
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- 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.
Who cannot join
- ● 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
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- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Headache Sciences Incorporated Laboratory
Toronto, Ontario, M4M1G9
Mark S. Doidge, MD, BA, 6472072504, headachesciences@gmail.com
Gaurav Anand, MD, BSc, 6479953374, 13gaurav.anand13@gmail.com
About this study
Official title: 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 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.
- Conditions
- Migraine, Chronic Migraine, Tension-Type Headache
- Being tested
- Machine Learning Test for Migraine
- Keywords
- EEG, Machine Learning, Migraine, Headache, Diagnosis, Artificial Intelligence
- Medical subject headings
- Migraine Disorders, Tension-Type Headache, Headache, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Machine Learning Test for MigraineDiagnostic test
Also called MLTM
Resting EEG, and Visual and Auditory Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Normal Control | These participants are normal control in good mental and psychiatric health. Receives: Diagnostic Test: Machine Learning Test for Migraine | |
| Migraine | These participants have migraines according to ICHD-3 criteria. Receives: Diagnostic Test: Machine Learning Test for Migraine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start3 Sep 2022
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Headache Sciences Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517200
- Sponsor's protocol ID
- MLTM1
- Acronym
- MLTM
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2022
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05517200
- Acronym / sponsor ID
- MLTM / MLTM1
- Conditions
- Migraine, Chronic Migraine, Tension-Type Headache
- Keywords
- EEG, Machine Learning, Migraine, Headache, Diagnosis, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Headache Sciences IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Control | – | Diagnostic Test: Machine Learning Test for MigraineThese participants are normal control in good mental and psychiatric health. |
| Migraine | – | Diagnostic Test: Machine Learning Test for MigraineThese participants have migraines according to ICHD-3 criteria. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- ● Age range: All participants and controls will be adults over 18, and no greater than 70
Key exclusion criteria (33 listed)
- ● Under 18 years old
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Machine Learning Test for MigraineAlso: MLTMResting EEG, and Visual and Auditory Stimulation | Diagnostic test | Migraine, Normal Control |
Primary outcome
Feasibility of machine learning as applied to EEG to diagnose migraine.
Time frame: 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- 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 SYSTEMLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Chronic Migraine, run by Headache Sciences Incorporated at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark S. Doidge, MD, BA (6472072504, headachesciences@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of machine learning as applied to EEG to diagnose migraine. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.