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

SunStar Project to Explore the Chronification Process in Headache Through Functional Imaging, Deep Phenotyping, and Analysis of CSF of Blood Products

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Migraine; Chronic Daily Headache

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.

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Bharati Sanjanwala, M.Sc.; Phone Number: 650-721-2830; Email: bharatis@stanford.edu
• Study Contact Backup: Name: Anthony Bet, B.S.; Phone Number: 650-683-5823; Email: abet0915@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University School of Medicine
      • Contact: Bharati Sanjanwala, M.Sc.; Phone Number: 650-721-2830; Email: bharatis@stanford.edu
      • Contact: Anthony Bet, B.S.; Phone Number: 650-683-5823; Email: abet0915@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Robert Cowan, MD, FAAN, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2014
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 14, 2017
• First Submitted That Met QC Criteria: July 25, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 18, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Migraine; Headaches; New Daily Persistent Headache (NDPH); Tension-Type Headache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache
• Other Study ID Numbers: SunStar

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No