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

Status: Unknown
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
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• ● 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.

Locations
Other Locations
Canada
Headache Sciences Incorporated Laboratory
RECRUITING
Toronto
Contact Information
Primary
Mark S. Doidge, MD, BA
headachesciences@gmail.com
6472072504
Backup
Gaurav Anand, MD, BSc
13gaurav.anand13@gmail.com
6479953374
Time Frame
Start Date: 2022-09-03
Completion Date: 2025-06
Participants
Target number of participants: 20
Treatments
Normal Control
These participants are normal control in good mental and psychiatric health.
Migraine
These participants have migraines according to ICHD-3 criteria.
Sponsors
Leads: Headache Sciences Incorporated

This content was sourced from clinicaltrials.gov