Assessing the Diagnostic Accuracy of an On-line Questionnaire for Diagnosis of Primary Headache Disorders

The worldwide current gold standard for diagnosing headaches is the International
Classification of Headache Disorders (ICHD 3 beta). Adhering strictly to ICHD criteria has
been problematic for accurately diagnosing patients in the clinic and as for clinical trials.
To address these issues, an online instrument was developed that successfully diagnosis
common primary and secondary headache disorders. In this research Investigator hopes to
demonstrate an on- line questionnaire is non inferior to a semi-structured interview for
accurately diagnosing different types of headaches (for example: episodic migraine vs. non
episodic migraine, chronic migraine vs. non chronic migraine, episodic tension-type vs.
non-episodic tension type, chronic tension-type headache vs. non chronic tension-type
headache, medication overuse headache vs. non medication overuse headache, post traumatic
headache vs. non post traumatic headache).

Participants will be screened by telephone to see if participants meet the criteria for
taking part in this research study. Once participant is deemed eligible,the participants will
then be randomized in a 1:1 ratio to complete either the semi-structured interview over the
phone first and then complete the online questionnaire or vice versa. Study is expected to
enroll 500 participants with headache and healthy controls.

Inclusion Criteria:

1. Female or male subjects age between age 18-65(inclusive),

2. Subjects must agree to sign online informed consent;

3. Subject must be able to understand and willing to complete both evaluations in English

4. Willing to comply with study instructions.

5. Agree not to Rely or act on any diagnosis given to them in the study

Exclusion Criteria:

1. Presence of Disorders listed in groups 5-13 of The International Headache Society
Classification of Head and Facial Pain (Headache Classification Committee of the
International Headache Society, 2015 except for post traumatic headache and medication
overuse headache);

1a. History of brain tumor, brain surgery

1b. History of brain infection such as meningitis, encephalitis, or meningoencephalitis

1c. History of any significant current or previous brain dysfunction

1d. Regular use of illicit drugs.

2. Known significant medical or psychiatric disease or abnormal laboratory data that would
preclude entry into this study.

3. Subjects with - significant cognitive impairment such as dementia, active psychiatric
disease such as schizophrenia.

4. Subjects with physical limitations to participate in the on-line or phone interview
impossible.

5. Non-English speaking patients