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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-03

Study Completion Date

2025-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Post-Traumatic Headache Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post-Traumatic Headache Group

Subjects diagnosed with having post-traumatic headache complete an MRI, speech sample, and electronic daily headache diary.

Brain Magnetic Resonance Imaging (MRI) Scan

Intervention Type DIAGNOSTIC_TEST

Imaging of the brain

Speech Sample

Intervention Type OTHER

Recorded reading aloud of pre-written words and sentences

Electronic Daily Headache Diary

Intervention Type OTHER

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.

Brain Magnetic Resonance Imaging (MRI) Scan

Intervention Type DIAGNOSTIC_TEST

Imaging of the brain

Speech Sample

Intervention Type OTHER

Recorded reading aloud of pre-written words and sentences

Interventions

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Brain Magnetic Resonance Imaging (MRI) Scan

Imaging of the brain

Intervention Type DIAGNOSTIC_TEST

Speech Sample

Recorded reading aloud of pre-written words and sentences

Intervention Type OTHER

Electronic Daily Headache Diary

Headache diary to provide information about headaches experience that day.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes