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

NCT07267819 | Recruiting

• 1 other identifier: USUHS.2025-154
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine; Traumatic Brain Injury; Anomalous Health Incidents

Keywords

Anomalous health incident; Traumatic brain injury; Headache; Migraine; Botulinumtoxin

Outcome Measures

Primary Outcomes (3)

• 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").

  Baseline, 4 weeks post-treatment, and 12 weeks post-treatment.

• 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.

  Baseline, 4 weeks post-treatment, and 12 weeks post-treatment.

• 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

  Baseline, 4 weeks post-treatment, and 12 weeks post-treatment.

Secondary Outcomes (1)

• Duration of Xeomin Effectiveness.

  Up to 12 weeks post-treatment.

Study Arms (2)

TBI Cohort

Patients with a history of Traumatic Brain Injury (TBI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 40.

Drug: Xeomin (incobotulinumtoxinA)

AHI Cohort

Patients with a history of Anomalous Health Incidents (AHI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 20.

Drug: Xeomin (incobotulinumtoxinA)

Interventions

Xeomin (incobotulinumtoxinA) DRUG

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.

AHI Cohort; TBI Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Employees of the US Government, or adult family members of US Government employees, receiving Xeomin treatment for migraine headache following either TBI or AHI.

You may qualify if:

• 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

You may not qualify if:

• Prisoner
• Decisionally impaired and unable to provide informed consent
• Non-US citizen

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead

Study Sites (1)

National Intrepid Center of Excellence (NICOE)

Bethesda, Maryland, 20814, United States

RECRUITING

Related Publications (16)

• Klein SK, Brown CB, Ostrowski-Delahanty S, Bruckman D, Victorio MC. Identifying Migraine Phenotype Post Traumatic Headache (MPTH) to Guide Overall Recovery From Traumatic Brain Injury. J Child Neurol. 2022 Jun 3:8830738221100327. doi: 10.1177/08830738221100327. Online ahead of print.

  PMID: 35656769 BACKGROUND

• Erickson JC. Treatment outcomes of chronic post-traumatic headaches after mild head trauma in US soldiers: an observational study. Headache. 2011 Jun;51(6):932-44. doi: 10.1111/j.1526-4610.2011.01909.x. Epub 2011 May 17.

  PMID: 21592097 BACKGROUND

• Becker WJ. Acute Migraine Treatment. Continuum (Minneap Minn). 2015 Aug;21(4 Headache):953-72. doi: 10.1212/CON.0000000000000192.

  PMID: 26252584 BACKGROUND

• Pringsheim T, Becker WJ. Triptans for symptomatic treatment of migraine headache. BMJ. 2014 Apr 7;348:g2285. doi: 10.1136/bmj.g2285. No abstract available.

  PMID: 24711666 BACKGROUND

• Theeler B, Lucas S, Riechers RG 2nd, Ruff RL. Post-traumatic headaches in civilians and military personnel: a comparative, clinical review. Headache. 2013 Jun;53(6):881-900. doi: 10.1111/head.12123.

  PMID: 23721236 BACKGROUND

• Chacko TP, Toole JT, Morris MC, Page J, Forsten RD, Barrett JP, Reinhard MJ, Brewster RC, Costanzo ME, Broderick G. A regulatory pathway model of neuropsychological disruption in Havana syndrome. Front Psychiatry. 2023 Oct 27;14:1180929. doi: 10.3389/fpsyt.2023.1180929. eCollection 2023.

  PMID: 37965360 BACKGROUND

• Aristi G, Kamintsky L, Ross M, Bowen C, Calkin C, Friedman A, Hashmi JA. Symptoms reported by Canadians posted in Havana are linked with reduced white matter fibre density. Brain Commun. 2022 Mar 7;4(2):fcac053. doi: 10.1093/braincomms/fcac053. eCollection 2022.

  PMID: 35505689 BACKGROUND

• Pierpaoli C, Nayak A, Hafiz R, Irfanoglu MO, Chen G, Taylor P, Hallett M, Hoa M, Pham D, Chou YY, Moses AD, van der Merwe AJ, Lippa SM, Brewer CC, Zalewski CK, Zampieri C, Turtzo LC, Shahim P, Chan L; NIH AHI Intramural Research Program Team; Moore B, Stamps L, Flynn S, Fontana J, Tata S, Lo J, Fernandez MA, Lori-Joseph A, Matsubara J, Goldberg J, Nguyen TD, Sasson N, Lely J, Smith B, King KA, Chisholm J, Christensen J, Magone MT, Cousineau-Krieger C, French LM, Yonter S, Attaripour S, Lai C. Neuroimaging Findings in US Government Personnel and Their Family Members Involved in Anomalous Health Incidents. JAMA. 2024 Apr 2;331(13):1122-1134. doi: 10.1001/jama.2024.2424.

  PMID: 38497822 BACKGROUND

• Swanson RL 2nd, Hampton S, Green-McKenzie J, Diaz-Arrastia R, Grady MS, Verma R, Biester R, Duda D, Wolf RL, Smith DH. Neurological Manifestations Among US Government Personnel Reporting Directional Audible and Sensory Phenomena in Havana, Cuba. JAMA. 2018 Mar 20;319(11):1125-1133. doi: 10.1001/jama.2018.1742.

  PMID: 29450484 BACKGROUND

• Ruff RL, Blake K. Pathophysiological links between traumatic brain injury and post-traumatic headaches. F1000Res. 2016 Aug 31;5:F1000 Faculty Rev-2116. doi: 10.12688/f1000research.9017.1. eCollection 2016.

  PMID: 27635228 BACKGROUND

• National Academies of Sciences, Engineering, and Medicine; Division on Engineering and Physical Sciences; Health and Medicine Division; Standing Committee to Advise the Department of State on Unexplained Health Effects on U.S. Government Employees and Their Families at Overseas Embassies; Pavlin JA, Relman DA, editors. An Assessment of Illness in U.S. Government Employees and Their Families at Overseas Embassies. Washington (DC): National Academies Press (US); 2020 Dec 5. Available from http://www.ncbi.nlm.nih.gov/books/NBK566407/

  PMID: 33411434 BACKGROUND

• Asadi-Pooya AA. Havana syndrome: a scoping review of the existing literature. Rev Environ Health. 2022 Aug 15;38(4):655-661. doi: 10.1515/reveh-2021-0182. Print 2023 Dec 15.

  PMID: 35962646 BACKGROUND

• Ashina H, Porreca F, Anderson T, Amin FM, Ashina M, Schytz HW, Dodick DW. Post-traumatic headache: epidemiology and pathophysiological insights. Nat Rev Neurol. 2019 Oct;15(10):607-617. doi: 10.1038/s41582-019-0243-8. Epub 2019 Sep 16.

  PMID: 31527806 BACKGROUND

• Lucas S, Hoffman JM, Bell KR, Dikmen S. A prospective study of prevalence and characterization of headache following mild traumatic brain injury. Cephalalgia. 2014 Feb;34(2):93-102. doi: 10.1177/0333102413499645. Epub 2013 Aug 6.

  PMID: 23921798 BACKGROUND

• Hoffman JM, Lucas S, Dikmen S, Temkin N. Clinical Perspectives on Headache After Traumatic Brain Injury. PM R. 2020 Oct;12(10):967-974. doi: 10.1002/pmrj.12338. Epub 2020 Mar 2.

  PMID: 32003524 BACKGROUND

• Walker WC, Seel RT, Curtiss G, Warden DL. Headache after moderate and severe traumatic brain injury: a longitudinal analysis. Arch Phys Med Rehabil. 2005 Sep;86(9):1793-800. doi: 10.1016/j.apmr.2004.12.042.

  PMID: 16181945 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Brain Injuries, Traumatic; Headache

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

David L Brody, MD, PhD

CONTACT

314-537-6453; David.brody@usuhs.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Uniformed Services University

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: December 5, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): June 6, 2028
• Study Completion (Estimated): June 6, 2028
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)