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

Mayo Clinic

Status

Completed

Conditions

Healthy

Post-Traumatic Headache

Treatments

Other: Speech Sample

Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan

Other: Electronic Daily Headache Diary

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT06132529

R61NS113315 (U.S. NIH Grant/Contract)

19-005203

Details and patient eligibility

About

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.

Enrollment

151 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.