Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Control | These participants are normal control in good mental and psychiatric health. |
| |
| Migraine | These participants have migraines according to ICHD-3 criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Machine Learning Test for Migraine | Diagnostic Test | Resting EEG, and Visual and Auditory Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
● Age range: All participants and controls will be adults over 18, and no greater than 70
Exclusion Criteria:
● Under 18 years old
4.2.2 EXCLUSION CRITERIA FOR NORMAL CONTROLS
4.2.3 EXCLUSION CRITERIA FOR MIGRAINE WITHOUT AURA:
● Chronic migraine without aura
4.2.4 EXCLUSION CRITERIA FOR TENSION-TYPE HEADACHES:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mark S. Doidge, MD, BA | Contact | 6472072504 | headachesciences@gmail.com | |
| Gaurav Anand, MD, BSc | Contact | 6479953374 | 13gaurav.anand13@gmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Headache Sciences Incorporated Laboratory | Recruiting | Toronto | Ontario | M4M1G9 | Canada |
Not provided
| Label | URL |
|---|---|
| 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 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D018781 | Tension-Type Headache |
| D006261 | Headache |
| D004194 | Disease |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |