MigraineNCT07267819
Efficacy of Xeomin for Migraines in Patients With Traumatic Brain Injuries vs. Anomalous Health Incidents
An observational study of Migraine and Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Traumatic Brain Injury, Anomalous Health Incidents
- What is being tested?
- Xeomin (incobotulinumtoxinA)
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2025to 6 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Prisoner
- Decisionally impaired and unable to provide informed consent
- Non-US citizen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Intrepid Center of Excellence (NICOE)
Bethesda, Maryland, 20814
David L Brody, MD, PhD, 314-537-6453, david.brody@usuhs.edu
Ananya Tripathi, MS, 443-876-0609, ananya.tripathi@usuhs.edu
About this study
Official title: The Efficacy of Xeomin as a Prophylactic Therapy for Migraine in Patients With Traumatic Brain Injuries (TBIs) Versus Anomalous Health Incidents (AHIs)
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.
Read the detailed description
Headaches with migraine-like characteristics are a common sequelae of traumatic brain injury (TBI)¹-⁴ and Havana syndrome, otherwise known as anomalous health incidents (AHIs).⁵,⁶ In TBI patients, direct biomechanical forces lead to cellular injury and neuroinflammation, contributing to post-traumatic headaches. Specifically, the disruption of trigeminovascular pathways and the release of inflammatory mediators, such as calcitonin gene-related peptide (CGRP), are implicated in the pathophysiology of post-traumatic migraines. Furthermore, the presence of comorbid conditions, such as post-concussive syndrome, can exacerbate headache symptoms and complicate treatment strategies.⁷ Though the migraine-like headaches in patients with AHI are clinically similar to those seen in patients with mTBI, the absence of clear structural damage on conventional neuroimaging in many AHI cases raises questions about the underlying mechanisms.⁸,⁹ Theories involving unknown exposure and subsequent disruption of white matter function have been proposed. Some analyses suggest that the symptoms of AHI could result from the disruption of neuroimmune and neurotransmission mechanisms similar to those affected in patients with TBI.¹⁰,¹¹
Managing post-traumatic headaches involves a multidisciplinary approach including behavioral therapy, physical therapy, oral medications, injectable medications, and interventional procedures. Essentially, these headaches can be treated similarly to the primary headache disorder they resemble.¹² Thus, the post-traumatic migraine can be treated in the acute setting with triptans, NSAIDs, ergot alkaloids, antiemetics, and other therapeutics.¹³,¹⁴ For chronic management, options include beta-blockers, tricyclic antidepressants, CGRP-targeting agents, anti-seizure medications, and many other medications.¹²,¹⁵ Onabotulinum toxin A (OBA) and other medications in the class of botulinum toxins have been particularly effective at reducing the overall frequency and duration of migraines in patients with TBIs,¹⁶,¹⁷ as well as non-TBI-related migraines. OBA results in a blockade of neural stimulation by inhibiting the release of neurotransmitters at the presynaptic terminal.¹⁸,¹⁹ It's thought to reduce the exocytosis of pain mediators (substance P, CGRP) from sensory neurons by cleaving SNAP25.²⁰,²¹ This effect is temporary due to the formation of new synapses, thus patients have to return for repeat injections every 10-12 weeks. Additionally, the number of units of OBA can be optimized to the patient's level of pain during each treatment.
There is limited literature on managing post-AHI headache disorders, but recent experience indicates that using multidisciplinary approaches similar to those used for TBI-related headache disorders may be appropriate.⁶ OBA, and more specifically incobotulinum toxin A (Xeomin brand) has therefore been a commonly used treatment modality in these patient populations in the Military Health System. Many individuals with AHIs from other branches of the government are treated in the MHS though the Secretarial Designee program.
While AHI symptoms might share pathophysiological characteristics with TBIs, there's limited research on Xeomin injections' characteristics in TBI vs. AHI patients, such as treatment frequency and efficacy. This study aims to quantify these similarities and differences in migraine management with Xeomin, potentially improving our understanding of this treatment modality. Migraines can disrupt home, work, and social activities, and treatment can be especially difficult in AHI patients who face limited effective treatment options that are evidence-based, and unique diagnostic challenges. By comparing Xeomin's efficacy in both groups, this study could reveal crucial differences in treatment response, leading to more personalized and effective therapies that align with a holistic healthcare model in medicine. The findings could inform clinical guidelines and improve migraine management in TBI and AHI patients, ultimately reducing the healthcare burden. This research is essential for addressing AHI patients' unmet needs and advancing migraine treatment understanding.
- Conditions
- Migraine, Traumatic Brain Injury, Anomalous Health Incidents
- Being tested
- Xeomin (incobotulinumtoxinA)
- Keywords
- Anomalous health incident, Traumatic brain injury, Headache, Migraine, Botulinumtoxin
- Medical subject headings
- Migraine Disorders, Brain Injuries, Traumatic, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| TBI Cohort | Patients with a history of Traumatic Brain Injury (TBI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 40. Receives: 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. Receives: Drug: Xeomin (incobotulinumtoxinA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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.
Measured: 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
Measured: Baseline, 4 weeks post-treatment, and 12 weeks post-treatment.
Secondary outcomes (1)
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.
Measured: Up to 12 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start5 Aug 2025
- Primary completion6 Jun 2028 (estimated)
- Study completion6 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, David Brody, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267819
- Sponsor's protocol ID
- USUHS.2025-154
- Status last verified
- Nov 2025
- First submitted
- 11 Sep 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol specifies that there are no data sharing or data use agreements in place for this research. The data collected is intended for internal analysis by authorized research personnel only. While de-identified, aggregate results may be published, the consent form assures participants that their individual data will not be shared in any way that would identify them.
Publications
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.
PubMed 35656769Erickson 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.
PubMed 21592097Becker WJ. Acute Migraine Treatment. Continuum (Minneap Minn). 2015 Aug;21(4 Headache):953-72. doi: 10.1212/CON.0000000000000192.
PubMed 26252584Pringsheim T, Becker WJ. Triptans for symptomatic treatment of migraine headache. BMJ. 2014 Apr 7;348:g2285. doi: 10.1136/bmj.g2285. No abstract available.
PubMed 24711666Theeler 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.
PubMed 23721236Chacko 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.
PubMed 37965360Aristi 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.
PubMed 35505689Pierpaoli 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.
PubMed 38497822Swanson 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.
PubMed 29450484Ruff 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.
PubMed 27635228National 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/
PubMed 33411434Asadi-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.
PubMed 35962646Ashina 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.
PubMed 31527806Lucas 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.
PubMed 23921798Hoffman 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.
PubMed 32003524
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Xeomin as a Prophylactic Therapy for Migraine in Patients With Traumatic Brain Injuries (TBIs) Versus Anomalous Health Incidents (AHIs)
- ClinicalTrials.gov ID
- NCT07267819
- Acronym / sponsor ID
- USUHS.2025-154
- Conditions
- Migraine, Traumatic Brain Injury, Anomalous Health Incidents
- Keywords
- Anomalous health incident, Traumatic brain injury, Headache, Migraine, Botulinumtoxin
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 6 Jun 2028 (estimated)
- Study completion
- 6 Jun 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Headaches with migraine-like characteristics are a common sequelae of traumatic brain injury (TBI)¹-⁴ and Havana syndrome, otherwise known as anomalous health incidents (AHIs).⁵,⁶ In TBI patients, direct biomechanical forces lead to cellular injury and neuroinflammation, contributing to post-traumatic headaches. Specifically, the disruption of trigeminovascular pathways and the release of inflammatory mediators, such as calcitonin gene-related peptide (CGRP), are implicated in the pathophysiology of post-traumatic migraines. Furthermore, the presence of comorbid conditions, such as post-concussive syndrome, can exacerbate headache symptoms and complicate treatment strategies.⁷ Though the migraine-like headaches in patients with AHI are clinically similar to those seen in patients with mTBI, the absence of clear structural damage on conventional neuroimaging in many AHI cases raises questions about the underlying mechanisms.⁸,⁹ Theories involving unknown exposure and subsequent disruption of white matter function have been proposed. Some analyses suggest that the symptoms of AHI could result from the disruption of neuroimmune and neurotransmission mechanisms similar to those affected in patients with TBI.¹⁰,¹¹
Managing post-traumatic headaches involves a multidisciplinary approach including behavioral therapy, physical therapy, oral medications, injectable medications, and interventional procedures. Essentially, these headaches can be treated similarly to the primary headache disorder they resemble.¹² Thus, the post-traumatic migraine can be treated in the acute setting with triptans, NSAIDs, ergot alkaloids, antiemetics, and other therapeutics.¹³,¹⁴ For chronic management, options include beta-blockers, tricyclic antidepressants, CGRP-targeting agents, anti-seizure medications, and many other medications.¹²,¹⁵ Onabotulinum toxin A (OBA) and other medications in the class of botulinum toxins have been particularly effective at reducing the overall frequency and duration of migraines in patients with TBIs,¹⁶,¹⁷ as well as non-TBI-related migraines. OBA results in a blockade of neural stimulation by inhibiting the release of neurotransmitters at the presynaptic terminal.¹⁸,¹⁹ It's thought to reduce the exocytosis of pain mediators (substance P, CGRP) from sensory neurons by cleaving SNAP25.²⁰,²¹ This effect is temporary due to the formation of new synapses, thus patients have to return for repeat injections every 10-12 weeks. Additionally, the number of units of OBA can be optimized to the patient's level of pain during each treatment.
There is limited literature on managing post-AHI headache disorders, but recent experience indicates that using multidisciplinary approaches similar to those used for TBI-related headache disorders may be appropriate.⁶ OBA, and more specifically incobotulinum toxin A (Xeomin brand) has therefore been a commonly used treatment modality in these patient populations in the Military Health System. Many individuals with AHIs from other branches of the government are treated in the MHS though the Secretarial Designee program.
While AHI symptoms might share pathophysiological characteristics with TBIs, there's limited research on Xeomin injections' characteristics in TBI vs. AHI patients, such as treatment frequency and efficacy. This study aims to quantify these similarities and differences in migraine management with Xeomin, potentially improving our understanding of this treatment modality. Migraines can disrupt home, work, and social activities, and treatment can be especially difficult in AHI patients who face limited effective treatment options that are evidence-based, and unique diagnostic challenges. By comparing Xeomin's efficacy in both groups, this study could reveal crucial differences in treatment response, leading to more personalized and effective therapies that align with a holistic healthcare model in medicine. The findings could inform clinical guidelines and improve migraine management in TBI and AHI patients, ultimately reducing the healthcare burden. This research is essential for addressing AHI patients' unmet needs and advancing migraine treatment understanding.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TBI Cohort | – | Drug: Xeomin (incobotulinumtoxinA)Patients with a history of Traumatic Brain Injury (TBI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 40. |
| AHI Cohort | – | Drug: Xeomin (incobotulinumtoxinA)Patients with a history of Anomalous Health Incidents (AHI) receiving Xeomin treatments for migraine management. The anticipated number of participants is 20. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Prisoner
- Decisionally impaired and unable to provide informed consent
- Non-US citizen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | AHI Cohort, TBI Cohort |
Primary outcome
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
1 secondary outcome
Duration of Xeomin Effectiveness.
Time frame: Up to 12 weeks post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Background: PubMed 35656769Klein 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.
- Background: PubMed 21592097Erickson 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.
- Background: PubMed 26252584Becker WJ. Acute Migraine Treatment. Continuum (Minneap Minn). 2015 Aug;21(4 Headache):953-72. doi: 10.1212/CON.0000000000000192.
- Background: PubMed 24711666Pringsheim T, Becker WJ. Triptans for symptomatic treatment of migraine headache. BMJ. 2014 Apr 7;348:g2285. doi: 10.1136/bmj.g2285. No abstract available.
- Background: PubMed 23721236Theeler 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.
- Background: PubMed 37965360Chacko 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.
- Background: PubMed 35505689Aristi 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.
- Background: PubMed 38497822Pierpaoli 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.
- Background: PubMed 29450484Swanson 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.
- Background: PubMed 27635228Ruff 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.
- Background: PubMed 33411434National 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/
- Background: PubMed 35962646Asadi-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.
- Individual participant dataSharing planned: No. The study protocol specifies that there are no data sharing or data use agreements in place for this research. The data collected is intended for internal analysis by authorized research personnel only. While de-identified, aggregate results may be published, the consent form assures participants that their individual data will not be shared in any way that would identify them.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Traumatic Brain Injury, run by Uniformed Services University of the Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David L Brody, MD, PhD (314-537-6453, David.brody@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07267819, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.