A Study to Evaluate Biomarker Signature to Predict the Persistence of Post-traumatic Headache
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Post-Traumatic Headache Group 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
Imaging of the brain
Other: Speech Sample
Recorded reading aloud of pre-written words and sentences
Other: Electronic Daily Headache Diary
Headache diary to provide information about headaches experience that day.
|
| Healthy Control Group Subjects identified as health and not having any headaches will complete an MRI and speech sample. |
Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan
Imaging of the brain
Other: Speech Sample
Recorded reading aloud of pre-written words and sentences
|
Outcome Measures
Primary Outcome Measures
- Prediction of post-traumatic headache recovery [6 years]
Using questionnaires and fMRI
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Health Care System | Phoenix | Arizona | United States | 85012 |
| 2 | Mayo Clinic Arizona | Phoenix | Arizona | United States | 85054 |
Sponsors and Collaborators
- Mayo Clinic
- National Institute of Neurological Disorders and Stroke (NINDS)
- Arizona State University
Investigators
- Principal Investigator: Catherine Chong, PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 19-005203
- R61NS113315