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Completed

NCT Number: NCT06132529

A Study to Evaluate 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Arizona, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain Magnetic Resonance Imaging (MRI) Scan

Diagnostic Test

Imaging of the brain

Speech Sample

Other

Recorded reading aloud of pre-written words and sentences

Electronic Daily Headache Diary

Other

Headache diary to provide information about headaches experience that day.

Primary outcomes

  1. Prediction of post-traumatic headache recovery

    Time frame: 6 years

    Using questionnaires and fMRI

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Arizona State University
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Biomarker Signature to Predict the Persistence of Post-traumatic Headache

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Nov 15, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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