Status:
COMPLETED
A Study to Evaluate Biomarker Signature to Predict the Persistence of Post-traumatic Headache
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Arizona State University
Conditions:
Post-Traumatic Headache
Healthy
Eligibility:
All Genders
18+ years
Brief 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. Res...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 3 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2025
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT06132529
Start Date
June 3 2019
End Date
July 31 2025
Last Update
August 29 2025
Active Locations (2)
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1
VA Health Care System
Phoenix, Arizona, United States, 85012
2
Mayo Clinic Arizona
Phoenix, Arizona, United States, 85054