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

NCT03304886 | Completed

• 1 other identifier: John Henry study
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study is to assess the diagnostic accuracy of an on- line questionnaire in comparison to a semi-structured interview administered by a trained interviewer.

Conditions

Headache Disorders

Outcome Measures

Primary Outcomes (1)

• On-line questionnaire accuracy for Diagnosing episodic migraine

  An on- line questionnaire is non inferior to a semi-structured interview for accurately diagnosing episodic migraine vs non episodic migraine, chronic migraine vs. non chronic migraine. We will compare the 4 primary (chronic and episodic migraine, chronic and episodic tension-type headache) obtained on each of the two evaluations for reliability using recognized statistical tools: This analysis will be conducted by independent reviewers, not the developers of either instrument

  2 -2.5 years

Study Arms (2)

Migraineurs

with a migraine

Control

Participants without migraine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All race, gender age between 18-65, English speaking selected from community, clinic.

You may qualify if:

• Female or male subjects age between age 18-65(inclusive),
• Subjects must agree to sign online informed consent;
• Subject must be able to understand and willing to complete both evaluations in English
• Willing to comply with study instructions.
• Agree not to Rely or act on any diagnosis given to them in the study

You may not qualify if:

• \. 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);
• a. History of brain tumor, brain surgery
• b. History of brain infection such as meningitis, encephalitis, or meningoencephalitis
• c. History of any significant current or previous brain dysfunction
• d. Regular use of illicit drugs.
• \. Known significant medical or psychiatric disease or abnormal laboratory data that would preclude entry into this study.
• \. Subjects with - significant cognitive impairment such as dementia, active psychiatric disease such as schizophrenia.
• \. Subjects with physical limitations to participate in the on-line or phone interview impossible.
• \. Non-English speaking patients

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• DeSouza DD, Woldeamanuel YW, Sanjanwala BM, Bissell DA, Bishop JH, Peretz A, Cowan RP. Altered structural brain network topology in chronic migraine. Brain Struct Funct. 2020 Jan;225(1):161-172. doi: 10.1007/s00429-019-01994-7. Epub 2019 Dec 2.

  PMID: 31792696 DERIVED

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Robert Cowan, MD, FAAN

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Chief, Division of Headache Medicine

Study Record Dates

• First Submitted: October 4, 2017
• First Posted: October 9, 2017
• Study Start: February 28, 2018
• Primary Completion: October 30, 2019
• Study Completion: December 30, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)