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

Active, not recruiting

• Conditions: Post-Traumatic Headache; Healthy
• Interventions: Diagnostic Test: Brain Magnetic Resonance Imaging (MRI) Scan; Other: Speech Sample; Other: Electronic Daily Headache Diary

• Registration Number: NCT06132529
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-03
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 260

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control Group	Speech Sample	Subjects identified as health and not having any headaches will complete an MRI and speech sample.
Post-Traumatic Headache Group	Brain Magnetic Resonance Imaging (MRI) Scan	Subjects diagnosed with having post-traumatic headache complete an MRI, speech sample, and electronic daily headache diary.
Post-Traumatic Headache Group	Speech Sample	Subjects diagnosed with having post-traumatic headache complete an MRI, speech sample, and electronic daily headache diary.
Healthy Control Group	Brain Magnetic Resonance Imaging (MRI) Scan	Subjects identified as health and not having any headaches will complete an MRI and speech sample.
Post-Traumatic Headache Group	Electronic Daily Headache Diary	Subjects diagnosed with having post-traumatic headache complete an MRI, speech sample, and electronic daily headache diary.

Primary Outcome Measures

Name	Time	Method
Prediction of post-traumatic headache recovery	6 years	Using questionnaires and fMRI

Trial Locations

Locations (2)

Mayo Clinic Arizona; 🇺🇸 Phoenix, Arizona, United States

VA Health Care System; 🇺🇸 Phoenix, Arizona, United States