Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents

Recruiting now

Conditions studied: Migraine, Traumatic Brain Injury, Anomalous Health Incidents

In brief

This cohort study aims to compare the efficacy of Xeomin injections for migraine management in patients with a history of Traumatic Brain Injury (TBI) versus those with a history of Anomalous Health Incidents (AHI). The study will be conducted at the National Intrepid Center of Excellence (NICOE) in Bethesda, MD. The primary objective is to determine if Xeomin injections result in different outcomes for migraine management between TBI and AHI patients. This is a combined retrospective and prospective cohort study design. Patients scheduled for Xeomin treatments will be categorized into TBI and AHI groups. For the prospective cohort, participants will complete a baseline questionnaire, receive their scheduled Xeomin treatment, and participate in follow-up interviews at 4-6 weeks and 10-12 weeks post-treatment. For the retrospective cohort, similar information will be acquired from existing records. Statistical analysis will compare migraine characteristics and treatment responses between the two groups. All data will be de-identified to protect patient privacy.

Key facts

Study ID

NCT07267819

Run by

Uniformed Services University of the Health Sciences

People needed

60

Starts

2025-08-05

Expected to finish

2028-06-06

Last updated by the study team

2025-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Able to provide written consent in English
• An employee of the US Government, or an adult family member of a US Government employee
• Have received Xeomin treatment to prevent migraine related to TBI or AHI at a Military Treatment Facility or other US Medical Facility
• Able to participate in at least 80% of the assessments
• A US Citizen and not a dual national of the country where you are currently located

You may not qualify if…

• Prisoner
• Decisionally impaired and unable to provide informed consent
• Non-US citizen

Where it is running

• National Intrepid Center of Excellence (NICOE) — Bethesda, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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