SunStar Project to Explore the Chronification Process in Headache Through Functional Imaging, Deep Phenotyping, and Analysis of CSF of Blood Products
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Stanford University
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- Prediction of chronification of headache
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Outcomes
Primary Outcomes
Prediction of chronification of headache
Time Frame: five years
Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.
Secondary Outcomes
No secondary outcomes reported
Investigators
Robert Cowan
Director and Chief, Division of Headache Medicine
Stanford University
