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

SunStar Project to Explore the Chronification Process in Headache Through Functional Imaging, Deep Phenotyping, and Analysis of CSF of Blood Products

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03231241
Enrollment
700
Registered
2017-07-27
Start date
2014-12-12
Completion date
2026-09-01
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Daily Headache, Chronic Migraine

Keywords

Headaches, Tension-Type Headache, New Daily Persistent Headache (NDPH), Migraine

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.

Interventions

None listed

Sponsors

Stanford University
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
Prediction of chronification of headachefive yearsBrain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.

Countries

United States

Contacts

Primary ContactBharati Sanjanwala, M.Sc.
bharatis@stanford.edu650-721-2830
Backup ContactAnthony Bet, B.S.
abet0915@stanford.edu650-683-5823

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026