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

Biomarker Signature to Predict the Persistence of Post-traumatic Headache

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06132529
Enrollment
151
Registered
2023-11-15
Start date
2019-06-03
Completion date
2025-07-31
Last updated
2025-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Post-Traumatic Headache

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.

Interventions

DIAGNOSTIC_TESTBrain Magnetic Resonance Imaging (MRI) Scan

Imaging of the brain

OTHERSpeech Sample

Recorded reading aloud of pre-written words and sentences

OTHERElectronic Daily Headache Diary

Headache diary to provide information about headaches experience that day.

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Arizona State University
CollaboratorOTHER
Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prediction of post-traumatic headache recovery6 yearsUsing questionnaires and fMRI

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026