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

This study is currently recruiting participants.
Verified July 2017 by Robert Cowan, Stanford University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03231241
First Posted: July 27, 2017
Last Update Posted: July 27, 2017
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.
Information provided by (Responsible Party):
Robert Cowan, Stanford University
  Purpose
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
Chronic Daily Headache Chronic Migraine

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Robert Cowan, Stanford University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 700
Actual Study Start Date: December 12, 2014
Estimated Study Completion Date: May 1, 2021
Estimated Primary Completion Date: August 15, 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
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.

Exclusion Criteria:

* Understand English.

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03231241


Contacts
Contact: Bharati Sanjanwala, M.Sc. 650-721-2830 bharatis@stanford.edu
Contact: Anthony Bet, B.S. 650-683-5823 abet0915@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94304
Contact: Bharati Sanjanwala, M.Sc.    650-721-2830    bharatis@stanford.edu   
Contact: Anthony Bet, B.S.    650-683-5823    abet0915@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Robert Cowan, MD, FAAN Stanford University
  More Information

Responsible Party: Robert Cowan, Director and Chief, Division of Headache Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03231241     History of Changes
Other Study ID Numbers: SunStar
First Submitted: July 14, 2017
First Posted: July 27, 2017
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not available.

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:
Headaches
Tension-Type Headache
New Daily Persistent Headache (NDPH)
Migraine

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders
Headache Disorders, Primary
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms