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NCT Number: NCT03231241

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Prediction of chronification of headache

    Time frame: five years

    Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.

Study contacts

Contact information is provided by the study sponsor or research team.

Anthony Bet, B.S.

CONTACT

[email protected]

650-683-5823

Bharati Sanjanwala, M.Sc.

CONTACT

[email protected]

650-721-2830

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2017
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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