Analysis of Headache Chronification With Imaging, Deep Ph... | NCT03231241

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

NCT03231241

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Jul 23, 2025Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Chronic Daily Headache
Chronic Migraine

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 12, 2014Actual

Primary Completion Date

Aug 15, 2026Estimated

Completion Date

Sep 1, 2026Estimated

First Submitted Date

Jul 14, 2017

First Submission Date that Met QC Criteria

Jul 25, 2017

First Posted Date

Jul 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2025

Last Update Posted Date

Jul 23, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Robert Cowan, Director and Chief, Division of Headache Medicine, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prediction of chronification of headache	Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.	five years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Anybody above 18 years of age regardless of their race, gender will be able to participate in this study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bharati Sanjanwala, M.Sc.	Contact	650-721-2830		bharatis@stanford.edu
Anthony Bet, B.S.	Contact	650-683-5823		abet0915@stanford.edu

Overall Officials

Name	Affiliation	Role
Robert Cowan, MD, FAAN	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University School of Medicine	Recruiting	Stanford	California	94304	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39314676	Derived	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.

ID	Term
D020773	Headache Disorders
D006261	Headache
D018781	Tension-Type Headache
D008881	Migraine Disorders

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D010146	Pain