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

Last updated: August 22, 2025
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

N/A

Condition

Pain

Chronic Pain

Pain (Pediatric)

Treatment

Speech Sample

Electronic Daily Headache Diary

Brain Magnetic Resonance Imaging (MRI) Scan

Clinical Study ID

NCT06132529
19-005203
R61NS113315
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Post-traumatic headache (PTH) and persistent post-traumatic headache (PPTH) will bediagnosed using the ICHD-3 diagnostic criteria for PTH attributed to mild traumaticbrain injury (concussion).

  • For patients with PTH, only patients with new onset of PTH without history of PPTHwill be included in the study.

  • A personal history of prior concussion and history of migraine are allowed accordingto ICHD-III diagnostic criteria.

  • Tension-type headaches on three or fewer days per month is allowed for healthycontrol subjects.

Exclusion

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/orpresence of ferrous materials in the body.

  • Women who are pregnant, or believe that they might be pregnant. Although there areno known contraindications or risks associated with pregnancy and MRI, we willexclude pregnant women or women who believe that there might be a chance that theyare 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) aboard-certified physician in Neurology and Headache Medicine. Presence of concussionwill be verified using the Ohio State University TBI Identification Method, astandardized questionnaire assessing the lifetime history of TBI for an individual.

Study Design

Total Participants: 151
Treatment Group(s): 3
Primary Treatment: Speech Sample
Phase:
Study Start date:
June 03, 2019
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • Mayo Clinic Arizona

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • VA Health Care System

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Mayo Clinic Arizona

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Site Not Available

  • VA Health Care System

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Site Not Available

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