A Study to Evaluate Biomarker Signature to Predict the Persistence of Post-traumatic Headache

Overview

About this study

The purpose of this study is to identify brain imaging and clinical feature biomarkers using machine-learning algorithms that distinguish individuals at high risk for developing persistent post-trauma headache (PPTH) from patients who are likely to acutely recover from PTH prior to three months.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

PTH and 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 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Catherine Chong, Ph.D.	Open for enrollment	Contact information: Dani Smith M.S. (480) 342-6524 Smith.Dani@mayo.edu

Mayo Clinic Location

Status

Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Catherine Chong, Ph.D.

Open for enrollment

Contact information:

Dani Smith M.S.

(480) 342-6524

Smith.Dani@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials