NCT03231241

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
4mo left

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Dec 2014Sep 2026

Study Start

First participant enrolled

December 12, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 23, 2025

Status Verified

December 1, 2024

Enrollment Period

11.7 years

First QC Date

July 14, 2017

Last Update Submit

July 18, 2025

Conditions

Keywords

HeadachesTension-Type HeadacheNew Daily Persistent Headache (NDPH)Migraine

Outcome Measures

Primary Outcomes (1)

  • Prediction of chronification of headache

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

    five years

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94304, United States

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal Fluid and Blood are collected and stored for analysis.

MeSH Terms

Conditions

Headache DisordersHeadacheTension-Type HeadacheMigraine Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsHeadache Disorders, Primary

Study Officials

  • Robert Cowan, MD, FAAN

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bharati Sanjanwala, M.Sc.

CONTACT

Anthony Bet, B.S.

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director and Chief, Division of Headache Medicine

Study Record Dates

First Submitted

July 14, 2017

First Posted

July 27, 2017

Study Start

December 12, 2014

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 23, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations