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RecruitingNCT03231241Updated Jul 23, 2025

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

An observational study in Chronic Daily Headache and Chronic Migraine, sponsored by Stanford University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Stanford University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
700
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Chronic Daily Headache
  • Chronic Migraine

Keywords

  • Headaches
  • Tension-Type Headache
  • New Daily Persistent Headache (NDPH)
  • Migraine
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

*Any neurological condition, at the discretion of the Principal Investigator (PI)

04

Study design

Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrollment
700 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Episodic Headache

    Participants experiencing headache of any type more than twice per year but less than 15 days per month. No interventions

  • Chronic Headache

    Participants experiencing headache more than 15 days per month for at least three consecutive months. No interventions

  • Control

    Participants reporting fewer than two headaches per year. No interventions

05

What researchers measure

Primary outcomes

  1. Prediction of chronification of headache

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

    Time frame: five years

06

Study locations

1 of 1 sites recruiting
  • Stanford University School of Medicine
    Stanford, California 94304, United States
    Recruiting
07

References and documents

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. PubMed 39314676 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03231241
Lead sponsor
Stanford University
Responsible party
Robert Cowan (Director and Chief, Division of Headache Medicine, Stanford University) — Principal investigator
First posted
Jul 27, 2017
Start date
Dec 12, 2014
Primary completion
Aug 15, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Jul 23, 2025

Study contacts

Bharati Sanjanwala, M.Sc.
Contact
bharatis@stanford.edu
650-721-2830
Anthony Bet, B.S.
Contact
abet0915@stanford.edu
650-683-5823
Robert Cowan, MD, FAAN
principal investigator · Stanford University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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