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

Biomarker Signature to Predict the Persistence of Post-traumatic Headache

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Post-Traumatic Headache
• Intervention / Treatment: Diagnostic test: Brain Magnetic Resonance Imaging (MRI) Scan; Other: Speech Sample; Other: Electronic Daily Headache Diary

• Study Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic Arizona
    • Phoenix, Arizona, United States, 85012
      • VA Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected through a multi-site collaboration between the Mayo Clinic Headache and Concussion Clinics in Arizona and the Phoenix VA Health Care System.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS); Arizona State University
• Investigators: Principal Investigator: Catherine Chong, PhD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2019
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Post-Traumatic Headache; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Diagnostic Techniques, Radioisotope; Magnetic Resonance Imaging; Radionuclide Imaging
• Other Study ID Numbers: 19-005203; R61NS113315 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No