Xeomin injections for migraines after traumatic brain injury versus anomalous health incidents
The Efficacy of Xeomin as a Prophylactic Therapy for Migraine in Patients With Traumatic Brain Injuries (TBIs) Versus Anomalous Health Incidents (AHIs)
This project will test if Xeomin injections reduce migraine symptoms in adults with a history of traumatic brain injury or an anomalous health incident.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Uniformed Services University of the Health Sciences Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT07267819 on ClinicalTrials.gov |
What this trial studies
This combined retrospective and prospective cohort study at the National Intrepid Center of Excellence (NICOE) in Bethesda, MD will compare migraine outcomes after Xeomin (incobotulinumtoxinA) between patients with prior traumatic brain injury (TBI) and those with anomalous health incidents (AHI). Prospective participants will complete a baseline questionnaire, receive their scheduled Xeomin treatment, and complete follow-up interviews at 4–6 weeks and 10–12 weeks post-treatment, while retrospective data will be extracted from existing records. Patients will be categorized into TBI and AHI groups and clinical characteristics and treatment responses will be compared using statistical analysis. The primary goal is to see whether migraine-related outcomes differ between the two groups following Xeomin treatment.
Who should consider this trial
Good fit: Adults aged 18 or older who are US citizens or adult family members of US government employees, able to consent in English, and who have received Xeomin for migraine related to TBI or AHI at a US medical facility are the intended participants.
Not a fit: People who are not US citizens, are decisionally impaired and unable to consent, prisoners, or those who have not received Xeomin for TBI- or AHI-related migraine are not likely to benefit from participating.
Why it matters
Potential benefit: If successful, the results could help tailor migraine treatment with Xeomin to people with TBI or AHI by showing whether they respond differently.
How similar studies have performed: Botulinum toxins have established benefit for chronic migraine in other settings, but Xeomin specifically and comparisons between TBI and AHI populations have been less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bethesda, Maryland
- National Intrepid Center of Excellence (NICOE) — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Study coordinator: David L Brody, MD, PhD
- Email: David.brody@usuhs.edu
- Phone: 314-537-6453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.