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

Study 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.

Official Title
-----------------
Biomarker Signature to Predict the Persistence of Post-traumatic Headache

Conditions
-----------------
Post-Traumatic Headache, Healthy

Intervention / Treatment
-----------------
* Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan
* Other: Speech Sample
* Other: Electronic Daily Headache Diary


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-Traumatic Headache Group<br>Subjects diagnosed with having post-traumatic headache complete an MRI, speech sample, and electronic daily headache diary. | Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan<br>* Imaging of the brain<br>Other: Speech Sample<br>* Recorded reading aloud of pre-written words and sentences<br>Other: Electronic Daily Headache Diary<br>* Headache diary to provide information about headaches experience that day.<br>|
| Healthy Control Group<br>Subjects identified as health and not having any headaches will complete an MRI and speech sample. | Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan<br>* Imaging of the brain<br>Other: Speech Sample<br>* Recorded reading aloud of pre-written words and sentences<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of post-traumatic headache recovery | Using questionnaires and fMRI | 6 years |