NCT07267819 · Uniformed Services University of the Health Sciences
Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents
What this study is about
This group of participants study aims to compare the effectiveness 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.
View original scientific description
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.
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.
Primary outcome measures
Percent Change in Migraine Headache Intensity from Baseline to Peak Effect (4 weeks post-treatment) and to wearing off (12 weeks post-treatment).
Time frame: Baseline, 4 weeks post-treatment, and 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).
Time frame: Baseline, 4 weeks post-treatment, and 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).
Time frame: Baseline, 4 weeks post-treatment, and 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Decisionally impaired and unable to provide informed consent
- Non-US citizen
Where
- Bethesda, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Dec 5, 2025 · Source of record for eligibility and locations