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RECRUITING
NCT07267819

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

Sponsor: Uniformed Services University of the Health Sciences

View on ClinicalTrials.gov

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.

Official title: The Efficacy of Xeomin as a Prophylactic Therapy for Migraine in Patients With Traumatic Brain Injuries (TBIs) Versus Anomalous Health Incidents (AHIs)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2025-08-05

Completion Date

2028-06-06

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

DRUG

Xeomin (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.

Locations (1)

National Intrepid Center of Excellence (NICOE)

Bethesda, Maryland, United States