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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03231241
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : October 14, 2020
Information provided by (Responsible Party):
Robert Cowan, Stanford University

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.

Condition or disease
Chronic Daily Headache Chronic Migraine

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.

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: SunStar Project to Explore the Chronification Process in Headache Through Functional Imaging, Deep Phenotyping, and Analysis of CSF of Blood Products
Actual Study Start Date : December 12, 2014
Estimated Primary Completion Date : August 15, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache

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
Participants reporting fewer than two headaches per year. No interventions

Primary Outcome Measures :
  1. Prediction of chronification of headache [ Time Frame: five years ]
    Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.

Biospecimen Retention:   Samples With DNA
Cerebrospinal Fluid and Blood are collected and stored for analysis.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03231241

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Contact: Bharati Sanjanwala, M.Sc. 650-721-2830
Contact: Anthony Bet, B.S. 650-683-5823

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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94304
Contact: Bharati Sanjanwala, M.Sc.    650-721-2830   
Contact: Anthony Bet, B.S.    650-683-5823   
Sponsors and Collaborators
Stanford University
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Principal Investigator: Robert Cowan, MD, FAAN Stanford University
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Responsible Party: Robert Cowan, Director and Chief, Division of Headache Medicine, Stanford University Identifier: NCT03231241    
Other Study ID Numbers: SunStar
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Robert Cowan, Stanford University:
Tension-Type Headache
New Daily Persistent Headache (NDPH)
Additional relevant MeSH terms:
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Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations