Biomarker Signature to Predict the Persistence of Post-traumatic Headache

Mayo Clinic2 sites in 1 country151 target enrollmentJune 3, 2019

ConditionsPost-Traumatic Headache Healthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Post-Traumatic Headache
Sponsor: Mayo Clinic
Enrollment: 151
Locations: 2
Primary Endpoint: Prediction of post-traumatic headache recovery
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 3, 2019

End Date

July 31, 2025

Last Updated

8 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Mayo Clinic

Responsible Party

Principal Investigator

Catherine (Cat) Chong

Principal Investigator

Mayo Clinic

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.