The Efficacy of Xeomin as a Prophylactic Therapy for Migraine in Patients With Traumatic Brain Injuries (TBIs) Versus Anomalous Health Incidents (AHIs)
Uniformed Services University of the Health Sciences
Summary
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.
Description
Headaches with migraine-like characteristics are a common sequelae of traumatic brain injury (TBI)¹-⁴ and Havana syndrome, otherwise known as anomalous health incidents (AHIs).⁵,⁶ In TBI patients, direct biomechanical forces lead to cellular injury and neuroinflammation, contributing to post-traumatic headaches. Specifically, the disruption of trigeminovascular pathways and the release of inflammatory mediators, such as calcitonin gene-related peptide (CGRP), are implicated in the pathophysiology of post-traumatic migraines. Furthermore, the presence of comorbid conditions, such as post-concus…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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
Interventions
- DrugXeomin (incobotulinumtoxinA)
Patients receive their scheduled Xeomin treatment as prescribed by their physician as part of their standard of care. The treatment protocol (dosage, injection sites, etc.) will be documented.
Location
- National Intrepid Center of Excellence (NICOE)Bethesda, Maryland