Clinical trial NCT03231241: Analysis of Headache Chronification with Imaging, Deep Phenotyping, and Proteomics
Official title: SunStar Project to Explore the Chronification Process in Headache Through Functional Imaging, Deep Phenotyping, and Analysis of CSF of Blood Products
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Daily Headache
Chronic Migraine
Keywords: Headaches
Tension-Type Headache
New Daily Persistent Headache (NDPH)
Migraine
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Anybody above 18 years of age regardless of their race, gender will be able to participate in this study.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Prediction of chronification of headache
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Robert Cowan, MD, FAAN
role: PRINCIPAL_INVESTIGATOR
References: