Chronic Daily HeadacheNCT03231241
Analysis of Headache Chronification With Imaging, Deep Phenotyping, and Proteomics
An observational study of Chronic Daily Headache and Chronic Migraine, run by Stanford University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Daily Headache, Chronic Migraine
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2014to 1 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Anybody above 18 years of age regardless of their race, gender will be able to participate in this study.
Who may be able to join
- 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
Who cannot join
- Any neurological condition, at the discretion of the Principal Investigator (PI)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University School of Medicine
Stanford, California, 94304
Bharati Sanjanwala, M.Sc., 650-721-2830, bharatis@stanford.edu
Anthony Bet, B.S., 650-683-5823, abet0915@stanford.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Daily Headache, Chronic Migraine
- Keywords
- Headaches, Tension-Type Headache, New Daily Persistent Headache (NDPH), Migraine
- Medical subject headings
- Headache Disorders, Headache, Tension-Type Headache, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prediction of chronification of headache
Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start12 Dec 2014
- Primary completion15 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Daily HeadacheStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Cowan, Stanford University
- Investigators
- Robert Cowan, MD, FAAN, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231241
- Sponsor's protocol ID
- SunStar
- Status last verified
- Dec 2024
- First submitted
- 14 Jul 2017
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Woldeamanuel YW, Sanjanwala BM, Cowan RP. Deep and unbiased proteomics, pathway enrichment analysis, and protein-protein interaction of biomarker signatures in migraine. Ther Adv Chronic Dis. 2024 Sep 18;15:20406223241274302. doi: 10.1177/20406223241274302. eCollection 2024.
PubMed 39314676
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SunStar Project to Explore the Chronification Process in Headache Through Functional Imaging, Deep Phenotyping, and Analysis of CSF of Blood Products
- ClinicalTrials.gov ID
- NCT03231241
- Acronym / sponsor ID
- SunStar
- Conditions
- Chronic Daily Headache, Chronic Migraine
- Keywords
- Headaches, Tension-Type Headache, New Daily Persistent Headache (NDPH), Migraine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 12 Dec 2014 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Anybody above 18 years of age regardless of their race, gender will be able to participate in this study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Any neurological condition, at the discretion of the Principal Investigator (PI)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction of chronification of headache
Time frame: five years
Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Derived from this study: PubMed 39314676Woldeamanuel YW, Sanjanwala BM, Cowan RP. Deep and unbiased proteomics, pathway enrichment analysis, and protein-protein interaction of biomarker signatures in migraine. Ther Adv Chronic Dis. 2024 Sep 18;15:20406223241274302. doi: 10.1177/20406223241274302. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Cowan, MD, FAAN principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Daily Headache and Chronic Migraine, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bharati Sanjanwala, M.Sc. (650-721-2830, bharatis@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of chronification of headache (time frame: five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03231241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.