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

Chronic Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03231241
• Other study ID #: SunStar
• Status: Recruiting
• Start date: December 12, 2014
• Est. completion date: September 1, 2026

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Bharati Sanjanwala, M.Sc.
• Phone: 650-721-2830
• Email: bharatis[@]stanford.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 1, 2026
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

• Understand English.

Related Conditions & MeSH terms

• Chronic Daily Headache
• Chronic Migraine
• Headache
• Headache Disorders

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of chronification of headache	Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.	five years