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

Healthy Clinical Trial

Official title:

Biomarker Signature to Predict the Persistence of Post-traumatic Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06132529
• Other study ID #: 19-005203
• Secondary ID: R61NS113315
• Status: Recruiting
• Start date: June 3, 2019
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: Dani Smith
• Phone: 480-642-6524
• Email: Smith.Dani[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Healthy
• Post-Traumatic Headache

Intervention

Diagnostic Test:
• Brain Magnetic Resonance Imaging (MRI) Scan
Imaging of the brain

Other:
• Speech Sample
Recorded reading aloud of pre-written words and sentences
• Electronic Daily Headache Diary
Headache diary to provide information about headaches experience that day.

Locations

Country	Name	City	State
United States	Mayo Clinic Arizona	Phoenix	Arizona
United States	VA Health Care System	Phoenix	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Arizona State University, National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of post-traumatic headache recovery	Using questionnaires and fMRI	6 years

External Links

•   Mayo Clinic Clinical Trials