ClinicalTrials.gg
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.

Primary conditionMigraine DisordersRegistry: Headache DisordersReclassifiedWhy we changed it
Registry
Headache Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Migraine Disorders
Why
  1. The study's listed conditions name Migraine Disorders, a narrower term within Headache Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Stanford University · Observational

From the registry’s dates

  • Started Dec 2014; still recruiting 11 years 10 months later.
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

Browse trials for

Keywords

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

In context

Migraine Disorders Reclassified

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 700 is above the median of 137 across 331 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.

Compared within Migraine Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Headache Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must agree to sign .
  • 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)

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

1 of 1 sites recruiting
08

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

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2014 (actual). Primary completion is estimated for Aug 2026, 140 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2017
First posted
Jul 27, 2017
StartActual
Dec 12, 2014
Primary completionEst.
Aug 15, 2026
CompletionEst.
Sep 1, 2026
Last update
Jul 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03231241
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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