Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
NCT ID: NCT05823766
Last Updated: 2025-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
300 participants
OBSERVATIONAL
2022-03-01
2027-02-28
Brief Summary
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Detailed Description
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The TRACK-EPI project aims to address the gaps in the existing literature and in the TRACK project regarding PTE. Post-traumatic epilepsy (PTE) is a common complication of traumatic brain injury (TBI), occurring in up to 20% of civilian patients and as many as 50% of military service members who suffer severe brain trauma, and 3-5% of those who suffer moderate TBI. Epilepsy resulting from brain trauma is often difficult to control with medical therapy, and is the cause of epilepsy in approximately 5% of patients referred to specialized epilepsy centers. PTE can be the result of TBI of any severity, although the risk is higher from severe TBI. PTE can arise through a variety of mechanisms, which may co-exist within a single patient. Focal brain injury, which results from penetrating trauma or focal contusions can result in epileptogenesis. Closed head injury can also produce diffuse injury, with shearing of axons and blood vessels, diffuse edema and ischemia, and secondary cellular damage through the release of inflammatory mediators. The clinical features of epilepsy, such as the frequency and severity of seizures, prevalence of associated co-morbidities, and responsiveness to therapy, may differ among these diverse mechanisms. Additionally, the neurophysiologic and imaging features of epileptogenicity also likely differ. Given the frequency of PTE, a more complete understanding of PTE etiology and prognosis is vital. Furthermore, it is likely that a sophisticated understanding of the subtypes of epilepsy resulting from brain trauma will be required to successfully develop anti-epileptogenic therapies.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Telephone Assessment Battery
TRACK-TBI participants may complete up to three annual telephone calls to assess outcome status and screen for PTE. These assessments will determine eligibility for the in-person study visit.
Telephone Outcome Assessment
Assessments will be administered over the telephone to evaluate participant outcome status and screen for PTE
Comprehensive Assessment Battery (CAB)
Participants who demonstrate decision-making capacity will be asked to complete the Comprehensive Assessment Battery (CAB). The CAB in-person is comprised of measures of cognition (i.e. attention, memory, information processing speed, executive functions), mood (i.e., depression, anxiety), social participation, subjective well-being, post-traumatic stress, interviews, global functional status measures, and a COVID-19 questionnaire.
In-Person Outcome Assessment
Assessments will be administered to evaluate participant outcome status
3T Magnetic Resonance Imaging (MRI)
Participants will be asked to complete a 3T MRI
Clinical Visit
Patients who screen positive for PTE will have an in-depth clinical visit
Blood Draw
Blood Draw for Plasma, DNA, Serum, RNA
EEG
An EEG will be performed on patients who screen positive for PTE at the clinical visit
Abbreviated Assessment Battery (AAB)
Participants who do not have decision-making capacity will be asked to complete a modified assessment battery, called the Abbreviated Assessment Battery (AAB). The AAB in-person assessment will administer the Speech Intelligibility, GOAT, and CAP and/or CRS-R to study participants.
In-Person Outcome Assessment
Assessments will be administered to evaluate participant outcome status
3T Magnetic Resonance Imaging (MRI)
Participants will be asked to complete a 3T MRI
Clinical Visit
Patients who screen positive for PTE will have an in-depth clinical visit
Blood Draw
Blood Draw for Plasma, DNA, Serum, RNA
EEG
An EEG will be performed on patients who screen positive for PTE at the clinical visit
TED Friend Controls
Participants enrolled in the TBI Endpoints Development (TED) cohort from 2017-2019 who did not experience a TBI prior to affiliated enrollment in TRACK-TBI will be asked to complete an assessment battery.
In-Person Outcome Assessment
Assessments will be administered to evaluate participant outcome status
3T Magnetic Resonance Imaging (MRI)
Participants will be asked to complete a 3T MRI
Blood Draw
Blood Draw for Plasma, DNA, Serum, RNA
Interventions
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In-Person Outcome Assessment
Assessments will be administered to evaluate participant outcome status
3T Magnetic Resonance Imaging (MRI)
Participants will be asked to complete a 3T MRI
Clinical Visit
Patients who screen positive for PTE will have an in-depth clinical visit
Blood Draw
Blood Draw for Plasma, DNA, Serum, RNA
EEG
An EEG will be performed on patients who screen positive for PTE at the clinical visit
Telephone Outcome Assessment
Assessments will be administered over the telephone to evaluate participant outcome status and screen for PTE
Eligibility Criteria
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Inclusion Criteria
1. Participation in TRACK-TBI Observational Study (Penn IRB # 825503 or local IRB) and/or Spreading Depolarizations II (SDII) (Penn IRB # 828395 or local IRB) who are at least two years post-injury and completed at least 1 GOSE during the TRACK-TBI follow-up assessments
2. Must complete at least one Telephone Assessment (and a recruitment phone call)
3. Endorsed any one of four post-traumatic epilepsy (PTE) items from the Patient Interview at the 6 month or later TRACK-TBI follow-up assessment, and did not have a diagnosis of epilepsy prior to the index TBI
4. Ability of participant or legally authorized representative to provide informed consent Cohort Orthopedic Controls
1\. Participation in TRACK-TBI Observational Study (Penn IRB # 825503 or local IRB) and/or Spreading Depolarizations II (SDII) (Penn IRB # 828395 or local IRB) who are at least two years post-injury and completed at least 1 GOSE during the TRACK-TBI follow-up assessments 2. Must complete at least one Telephone Assessment (and a recruitment phone call) 3. Endorsed any one of four post-traumatic epilepsy (PTE) items from the Patient Interview at the 6 month or later TRACK-TBI follow-up assessment, and did not have a diagnosis of epilepsy prior to the index TBI 4. Ability of participant or legally authorized representative to provide informed consent 5. Initial TRACK-TBI orthopedic injury Cohort Friend Controls
1. Participation in TRACK-TBI Observational Study (Penn IRB # 825503 or local IRB) who are at least two years post-enrollment and completed at least 1 MRI during the TRACK-TBI follow-up assessments
2. Ability of participant or legally authorized representative to provide informed consent Participation in TED: Friend Controls Study (IRB # 827537)
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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United States Department of Defense
FED
University of Pennsylvania
OTHER
Responsible Party
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Locations
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University of California, San Francisco
San Francisco, California, United States
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas at Austin
Austin, Texas, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Other Identifiers
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834420
Identifier Type: -
Identifier Source: org_study_id
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