Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents
Recruiting · NCT07267819 · Observational (researchers observe without assigning treatment) · Lead sponsor: Uniformed Services University of the Health Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- Prisoner
- Decisionally impaired and unable to provide informed consent
- Non-US citizen
Where it is running
1 location listed across 1 US state.
- National Intrepid Center of Excellence (NICOE) - Bethesda, Maryland, United States