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.|
|ClinicalTrials.gov Identifier: NCT03231241|
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : July 27, 2017
|Condition or disease|
|Chronic Daily Headache Chronic Migraine|
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|
|Estimated Enrollment :||700 participants|
|Observational Model:||Ecologic or Community|
|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, 2020|
|Estimated Study Completion Date :||May 1, 2021|
Participants experiencing headache of any type more than twice per year but less than 15 days per month. No interventions
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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231241
|Contact: Bharati Sanjanwala, M.Sc.||firstname.lastname@example.org|
|Contact: Anthony Bet, B.S.||email@example.com|
|United States, California|
|Stanford University School of Medicine||Recruiting|
|Stanford, California, United States, 94304|
|Contact: Bharati Sanjanwala, M.Sc. 650-721-2830 firstname.lastname@example.org|
|Contact: Anthony Bet, B.S. 650-683-5823 email@example.com|
|Principal Investigator:||Robert Cowan, MD, FAAN||Stanford University|