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Analysis of Headache Chronification with Imaging, Deep Phenotyping, and Proteomics

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Stanford University

Status

Enrolling

Conditions

Chronic Migraine
Chronic Daily Headache

Study type

Observational

Funder types

Other

Identifiers

NCT03231241
SunStar

Details and patient eligibility

About

Study is aimed at determining why some patients with episodic headache proceed to chronic daily or near daily headaches. The Investigators seek to discover differences in brain anatomy and function, composition of cerebrospinal fluid, blood products, genetics, and patient phenotypes that might help explain this process.

Full description

The purpose of our study is to better understand disease processes and risk factors involved in onset of chronic daily headaches/Chronic Migraines. Further, The Investigators hopes to learn more about the etiology and disease mechanisms to optimize treatment strategies and determine prophylactic measures.

Participation in this research study, will include online questionnaires, a blood sample, a lumbar puncture, and a magnetic resonance imaging (MRI) scan without contrast to measure brain activity. Participant may select to participate in a magnetic resonance imaging (MRI) scan and/ or lumbar puncture. participating in atleast 3 procedures is required (blood draw, online questionnaires , MRI and/or Spinal Tap.

The study recruits participants with headache ( any type of headaches), and patients with no headaches ( or less than 2/year). Participants do not need to have a specified headache type. All participants are asked to complete an on-line survey to characterize a number of phenotypic features felt to be relevant by the Investigators. Three independent study groups (imaging, proteomics/genetics, and phenotyping) analyze data independently and stratify the data. Then, by group analysis, correlation among the different modalities is sought to identify features that distinguish common elements that might help elucidate features that could predict which patients with episodic headache are likely to progress to chronic, and which patients without headache might be at greater risk to develop new daily persistent headache.

Enrollment

700 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Subjects must agree to sign informed consent.
  • Subject must be able to or at least with some help willing to complete online questionnaires in English .
  • Willing to comply with study instructions.
  • must speak and understand English

Exclusion criteria

*Any neurological condition, at the discretion of the Principal Investigator (PI)

Trial design

700 participants in 3 patient groups

Episodic Headache
Description:
Participants experiencing headache of any type more than twice per year but less than 15 days per month. No interventions
Chronic Headache
Description:
Participants experiencing headache more than 15 days per month for at least three consecutive months. No interventions
Control
Description:
Participants reporting fewer than two headaches per year. No interventions

Trial contacts and locations

1

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Central trial contact

Anthony Bet, B.S.; Bharati Sanjanwala, M.Sc.

Data sourced from clinicaltrials.gov

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