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

NCT06132529 | Completed

• 2 other identifiers: 19-005203R61NS113315
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-Traumatic Headache; Healthy

Outcome Measures

Primary Outcomes (1)

• Prediction of post-traumatic headache recovery

  Using questionnaires and fMRI

  6 years

Study Arms (2)

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; Other: Speech Sample; Other: Electronic Daily Headache Diary

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; Other: Speech Sample

Interventions

Brain Magnetic Resonance Imaging (MRI) Scan DIAGNOSTIC_TEST

Imaging of the brain

Healthy Control Group; Post-Traumatic Headache Group

Speech Sample OTHER

Recorded reading aloud of pre-written words and sentences

Healthy Control Group; Post-Traumatic Headache Group

Electronic Daily Headache Diary OTHER

Headache diary to provide information about headaches experience that day.

Post-Traumatic Headache Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• Arizona State University: collaborator

Study Sites (2)

VA Health Care System

Phoenix, Arizona, 85012, United States

Location

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Magnetic Resonance Imaging; Radionuclide Imaging

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Catherine Chong, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: November 15, 2023
• Study Start: June 3, 2019
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)