Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
1 other identifier
observational
300
1 country
9
Brief Summary
The overarching goal of this study is to improve understanding of the long-range natural history of TBI and post-traumatic epilepsy (PTE) by extending follow-up of a previously enrolled cohort (TRACK-TBI) beyond the first 12 months after injury.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 10, 2023
CompletedFirst Posted
Study publicly available on registry
April 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
ExpectedMarch 9, 2026
March 1, 2026
4.1 years
April 10, 2023
March 5, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Glasgow Outcome Scale Extended (GOSE)
The GOSE provides an overall measure of functional status based on information on cognition, independence, employability, and social/community participation collected via structured interview. Individuals are described by one of the eight outcome categories: Dead (1); Vegetative State (2); Lower Severe Disability (3); Upper Severe Disability (4); Lower Moderate Disability (5); Upper Moderate Disability (6); Lower Good Recovery (7) and Upper Good Recovery (8). Good Recovery is defined as a score of 7-8, Moderate Disability is defined by a score of 5-6 and Severe Disability is defined by a score of 3-4.
4-6 years after TRACK-TBI enrollment
Diagnostic Interview for Seizure Classification Outside of Video EEG Recording (DISCOVER)
During the clinical evaluation, participants and their caregivers are educated about the heterogeneous and protean manifestations of epileptic seizures, and encouraged to contact study staff if seizures or seizure-like events are noted. The DISCOVER form has been found to be highly accurate when compared to gold-standard video-EEG recording in an Epilepsy Monitoring Unit for classifying seizures
4-6 years after TRACK-TBI enrollment
Secondary Outcomes (1)
Serum NF-L (neurofilament light chain)
4-6 years after TRACK-TBI enrollment
Study Arms (4)
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.
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.
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.
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.
Interventions
Patients who screen positive for PTE will have an in-depth clinical visit
Assessments will be administered to evaluate participant outcome status
Participants will be asked to complete a 3T MRI
Blood Draw for Plasma, DNA, Serum, RNA
An EEG will be performed on patients who screen positive for PTE at the clinical visit
Assessments will be administered over the telephone to evaluate participant outcome status and screen for PTE
Eligibility Criteria
Participants enrolled in TRACK-TBI who screen positive for PTE or participants enrolled in TED Friend Controls cohort
You may qualify if:
- Cohort TBI subjects with PTE
- 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
- Must complete at least one Telephone Assessment (and a recruitment phone call)
- 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
- Ability of participant or legally authorized representative to provide informed consent Cohort Orthopedic Controls
- \. 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
- 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
- Ability of participant or legally authorized representative to provide informed consent Participation in TED: Friend Controls Study (IRB # 827537)
You may not qualify if:
- \. Epilepsy diagnosed prior to index TBI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- United States Department of Defensecollaborator
Study Sites (9)
University of California, San Francisco
San Francisco, California, 94110, United States
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
University of Texas at Austin
Austin, Texas, 78712, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98104, United States
Biospecimen
Serum, plasma, PAXGene
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2023
First Posted
April 21, 2023
Study Start
March 1, 2022
Primary Completion
April 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share