Clinical trial NCT06132529: A Study to Evaluate Biomarker Signature to Predict the Persistence of Post-traumatic Headache
Official title: Biomarker Signature to Predict the Persistence of Post-traumatic Headache
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Post-Traumatic Headache
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: Arizona State University
First posted: 2023-11-15
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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. 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Prediction of post-traumatic headache recovery
timeFrame: 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: VA Health Care System
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Catherine Chong, PhD
role: PRINCIPAL_INVESTIGATOR
References: