Post-Traumatic HeadacheNCT06132529
A Study to Evaluate Biomarker Signature to Predict the Persistence of Post-traumatic Headache
An observational study of Post-Traumatic Headache and Healthy, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research study is to develop a model to help distinguish patients at high-risk for developing persistent post-traumatic headache from patients who experience headache recovery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Headache, Healthy
- What is being tested?
- Brain Magnetic Resonance Imaging (MRI) Scan, Speech Sample and Electronic Daily Headache Diary
- How many people
- 151 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Jun 2019to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Subjects will be selected through a multi-site collaboration between the Mayo Clinic Headache and Concussion Clinics in Arizona and the Phoenix VA Health Care System.
Who may be able to join
- Post-traumatic headache (PTH) and persistent post-traumatic headache (PPTH) will be diagnosed using the ICHD-3 diagnostic criteria for PTH attributed to mild traumatic brain injury (concussion).
- For patients with PTH, only patients with new onset of PTH without history of PPTH will be included in the study.
- A personal history of prior concussion and history of migraine are allowed according to ICHD-III diagnostic criteria.
- Tension-type headaches on three or fewer days per month is allowed for healthy control subjects.
Who cannot join
- History of moderate or severe traumatic brain injurie (TBI).
- Prior history of gross anatomical change on imaging.
- Contraindication to MRI, including but not limited to severe claustrophobia and/or presence of ferrous materials in the body.
- Women who are pregnant, or believe that they might be pregnant. Although there are no known contraindications or risks associated with pregnancy and MRI, we will exclude pregnant women or women who believe that there might be a chance that they are pregnant.
- History of concussion or more severe TBI.
- History of migraine or other headaches.
- The diagnosis for PTH and PPTH will be verified by Dr. Schwedt (co-investigator) a board-certified physician in Neurology and Headache Medicine. Presence of concussion will be verified using the Ohio State University TBI Identification Method, a standardized questionnaire assessing the lifetime history of TBI for an individual.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Health Care System
Phoenix, Arizona, 85012
Mayo Clinic Arizona
Phoenix, Arizona, 85054
About this study
Official title: Biomarker Signature to Predict the Persistence of Post-traumatic Headache
The purpose of this research study is to develop a model to help distinguish patients at high-risk for developing persistent post-traumatic headache from patients who experience headache recovery. Researchers will do this by comparing the brain images, clinical data, and speech of healthy controls to people who have been diagnosed with post-traumatic headache.
- Conditions
- Post-Traumatic Headache, Healthy
- Being tested
- Brain Magnetic Resonance Imaging (MRI) Scan, Speech Sample, Electronic Daily Headache Diary
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Magnetic Resonance Imaging (MRI) ScanDiagnostic test
Imaging of the brain
Speech SampleOther
Recorded reading aloud of pre-written words and sentences
Electronic Daily Headache DiaryOther
Headache diary to provide information about headaches experience that day.
| Study group | Role | What they receive |
|---|---|---|
| Post-Traumatic Headache Group | Subjects diagnosed with having post-traumatic headache complete an MRI, speech sample, and electronic daily headache diary. Receives: Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan; Other: Speech Sample; Other: Electronic Daily Headache Diary | |
| Healthy Control Group | Subjects identified as health and not having any headaches will complete an MRI and speech sample. Receives: Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan; Other: Speech Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of post-traumatic headache recovery
Using questionnaires and fMRI
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start3 Jun 2019
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Arizona State University
- Responsible party
- Principal investigator, Catherine (Cat) Chong, Mayo Clinic
- Investigators
- Catherine Chong, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132529
- Sponsor's protocol ID
- 19-005203
- Other IDs
- R61NS113315
- Status last verified
- Aug 2025
- First submitted
- 25 Oct 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Signature to Predict the Persistence of Post-traumatic Headache
- ClinicalTrials.gov ID
- NCT06132529
- Acronym / sponsor ID
- 19-005203
- Conditions
- Post-Traumatic Headache, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS), Arizona State University
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 15 Nov 2023 (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.
The purpose of this research study is to develop a model to help distinguish patients at high-risk for developing persistent post-traumatic headache from patients who experience headache recovery. Researchers will do this by comparing the brain images, clinical data, and speech of healthy controls to people who have been diagnosed with post-traumatic headache.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-Traumatic Headache Group | – | Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan, Other: Speech Sample, Other: Electronic Daily Headache DiarySubjects diagnosed with having post-traumatic headache complete an MRI, speech sample, and electronic daily headache diary. |
| Healthy Control Group | – | Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan, Other: Speech SampleSubjects identified as health and not having any headaches will complete an MRI and speech sample. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected through a multi-site collaboration between the Mayo Clinic Headache and Concussion Clinics in Arizona and the Phoenix VA Health Care System.
Key inclusion criteria (4 listed)
- Post-traumatic headache (PTH) and persistent post-traumatic headache (PPTH) will be diagnosed using the ICHD-3 diagnostic criteria for PTH attributed to mild traumatic brain injury (concussion).
- For patients with PTH, only patients with new onset of PTH without history of PPTH will be included in the study.
- A personal history of prior concussion and history of migraine are allowed according to ICHD-III diagnostic criteria.
- Tension-type headaches on three or fewer days per month is allowed for healthy control subjects.
Key exclusion criteria (7 listed)
- History of moderate or severe traumatic brain injurie (TBI).
- Prior history of gross anatomical change on imaging.
- Contraindication to MRI, including but not limited to severe claustrophobia and/or presence of ferrous materials in the body.
- Women who are pregnant, or believe that they might be pregnant. Although there are no known contraindications or risks associated with pregnancy and MRI, we will exclude pregnant women or women who believe that there might be a chance that they are pregnant.
- History of concussion or more severe TBI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Magnetic Resonance Imaging (MRI) ScanImaging of the brain | Diagnostic test | Healthy Control Group, Post-Traumatic Headache Group |
| Speech SampleRecorded reading aloud of pre-written words and sentences | Other | Healthy Control Group, Post-Traumatic Headache Group |
| Electronic Daily Headache DiaryHeadache diary to provide information about headaches experience that day. | Other | Post-Traumatic Headache Group |
Primary outcome
Prediction of post-traumatic headache recovery
Time frame: 6 years
Using questionnaires and fMRI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Catherine Chong, PhD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Headache and Healthy, run by Mayo Clinic at 2 sites 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 7 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: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of post-traumatic headache recovery (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2025.