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Recruiting NCT03231241

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

Observational Chronic Daily Headache Chronic Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Chronic Daily Headache, Chronic Migraine. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Prediction of chronification of headache [Time frame: five years]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Ecologic or community

Study locations

United States · 1 center
  • Stanford University School of Medicine — Stanford

Publications

  • Woldeamanuel YW, Sanjanwala BM, Cowan RP. Deep and unbiased proteomics, pathway enrichment analysis, and protein-protein interaction of biomarker signatures in migraine. Ther Adv Chronic Dis. 2024 Sep 18;15:20406223241274302. doi: 10.1177/20406223241274302. eCollection 2024. PMID 39314676

Identifiers

NCT: NCT03231241 · SunStar

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗