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.
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
Prisoner
Decisionally impaired and unable to provide informed consent
Non-US citizen
Employees of the US Government, or adult family members of US Government employees, receiving Xeomin treatment for migraine headache following either TBI or AHI.
Cohort
Other
Xeomin (incobotulinumtoxinA)
DrugPatients 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.
Percent Change in Migraine Headache Intensity from Baseline to Peak Effect (4 weeks post-treatment) and to wearing off (12 weeks post-treatment).
Comparison between TBI and AHI groups in the percent change of migraine headache intensity. Intensity is assessed using a 0-10 Numeric Rating Scale (NRS) in response to the question, "How painful were the migraine headaches typically at their worst (0-10)?". For this scale, 0 indicates 'no pain' and 10 indicates the 'worst imaginable pain,' where a higher score signifies a worse outcome. The change is measured from baseline ("Before you started Xeomin treatments") to peak effect ("When your Xeomin was at its peak effect").
Percent Change in Migraine Headache Frequency from Baseline to Peak Effect (4 weeks post-treatment) and to wearing off (12 weeks post-treatment).
Comparison between TBI and AHI groups in the percent change of migraine headache frequency. Frequency is defined as the total number of migraine headaches in a typical week, as reported on a patient questionnaire. The minimum value for this count is 0, and a higher number indicates a worse outcome. The change is measured from baseline to the time of the treatment's peak effects.
Percent Change in Headache Impact Test (HIT-6) Score from Baseline to Peak Effect (4 weeks post-treatment) and to wearing off (12 weeks post-treatment).
Comparison between TBI and AHI groups in the percent change in the Headache Impact Test (HIT-6) score. The HIT-6 is a 6-item questionnaire assessing the impact of headaches on daily life. Patient responses ("Never," "Rarely," "Sometimes," "Very Often," "Always") are converted to a numerical score. The total score ranges from 36 to 78, where a higher score indicates a more severe headache impact, representing a worse outcome. The change is measured from baseline to the time of the treatment's peak effects
Duration of Xeomin Effectiveness.
Comparison between TBI and AHI groups regarding the timeline of Xeomin effectiveness, including time to onset of effects and duration of benefits.
Click on the lead sponsor to view all of their trials.
