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

NCT ID: NCT03231241

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-12

Study Completion Date

2026-09-01

Brief Summary

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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

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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.

Conditions

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Chronic Daily Headache Chronic Migraine

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Episodic Headache

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

No interventions assigned to this group

Chronic Headache

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

No interventions assigned to this group

Control

Participants reporting fewer than two headaches per year. No interventions

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Robert Cowan

Director and Chief, Division of Headache Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Cowan, MD, FAAN

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Bharati Sanjanwala, M.Sc.

Role: CONTACT

650-721-2830

Anthony Bet, B.S.

Role: CONTACT

650-683-5823

Facility Contacts

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Bharati Sanjanwala, M.Sc.

Role: primary

650-721-2830

Anthony Bet, B.S.

Role: backup

650-683-5823

References

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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.

Reference Type DERIVED
PMID: 39314676 (View on PubMed)

Other Identifiers

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SunStar

Identifier Type: -

Identifier Source: org_study_id

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