Traumatic Brain InjuryNCT05823766
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
An observational study of Traumatic Brain Injury and Post-traumatic Epilepsy, run by University of Pennsylvania at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Post-traumatic Epilepsy
- What is being tested?
- In-Person Outcome Assessment, 3T Magnetic Resonance Imaging (MRI) and Clinical Visit
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 300 participants
- Where
- 9 sitesUnited States
- Study dates
- 1 Mar 2022to 30 Jun 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants enrolled in TRACK-TBI who screen positive for PTE or participants enrolled in TED Friend Controls cohort
Who may be able to join
- 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
- 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
- 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)
Who cannot join
- 1. Epilepsy diagnosed prior to index TBI
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Texas at Austin
Austin, Texas, 78712
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
University of Cincinnati
Cincinnati, Ohio, 45267
University of Texas Southwestern
Dallas, Texas, 75390
Baylor College of Medicine
Houston, Texas, 77030
University of Pennsylvania/Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of California, San Francisco
San Francisco, California, 94110
University of Washington
Seattle, Washington, 98104
About this study
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.
Read the detailed description
This longitudinal observational study is part of the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) initiative, a multi-institutional project designed to characterize the acute and longer-term clinical, neuroimaging, and blood biomarker features of TBI. TRACK-TBI enrolled TBI patients at 18 Level 1 Trauma Centers in the US, across the age and injury spectrum. This study will extend the follow-up period for TRACK-TBI participants. The extensive clinical, imaging, and biomarker data that has already been collected in these TRACK-TBI participants, in combination with the extended longitudinal data, will allow for the identification of risk factors, co-morbidities, and prognostic biomarkers of TBI. Consequently, the extension of study follow-up will help to determine negative neurological and psychological outcomes of individuals who experienced a TBI compared to healthy and orthopedic controls.
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
- Traumatic Brain Injury, Post-traumatic Epilepsy
- Being tested
- In-Person Outcome Assessment, 3T Magnetic Resonance Imaging (MRI), Clinical Visit, Blood Draw, EEG
- Medical subject headings
- Brain Injuries, Traumatic, Epilepsy, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-Person Outcome AssessmentBehavioural
Assessments will be administered to evaluate participant outcome status
3T Magnetic Resonance Imaging (MRI)Procedure or surgery
Participants will be asked to complete a 3T MRI
Clinical VisitBehavioural
Patients who screen positive for PTE will have an in-depth clinical visit
Blood DrawProcedure or surgery
Blood Draw for Plasma, DNA, Serum, RNA
EEGProcedure or surgery
An EEG will be performed on patients who screen positive for PTE at the clinical visit
Telephone Outcome AssessmentBehavioural
Assessments will be administered over the telephone to evaluate participant outcome status and screen for PTE
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Telephone Outcome Assessment | |
| 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. Receives: Behavioral: In-Person Outcome Assessment; Procedure: 3T Magnetic Resonance Imaging (MRI); Behavioral: Clinical Visit; Procedure: Blood Draw; Procedure: EEG | |
| 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. Receives: Behavioral: In-Person Outcome Assessment; Procedure: 3T Magnetic Resonance Imaging (MRI); Behavioral: Clinical Visit; Procedure: Blood Draw; Procedure: EEG | |
| 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. Receives: Behavioral: In-Person Outcome Assessment; Procedure: 3T Magnetic Resonance Imaging (MRI); Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4-6 years after TRACK-TBI enrollment
Secondary outcomes (1)
Serum NF-L (neurofilament light chain)
Using advanced blood-based assay platforms, levels of blood biomarkers neurofilament light chain (NF-L) will be measured to validate the utility as a biomarkers for traumatic axonal injury (TAI).
Measured: 4-6 years after TRACK-TBI enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Mar 2022
- Primary completion1 Oct 2026
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823766
- Sponsor's protocol ID
- 834420
- Status last verified
- Nov 2026
- First submitted
- 10 Apr 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
- ClinicalTrials.gov ID
- NCT05823766
- Acronym / sponsor ID
- 834420
- Conditions
- Traumatic Brain Injury, Post-traumatic Epilepsy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Apr 2023 (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.
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.
Detailed description
This longitudinal observational study is part of the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) initiative, a multi-institutional project designed to characterize the acute and longer-term clinical, neuroimaging, and blood biomarker features of TBI. TRACK-TBI enrolled TBI patients at 18 Level 1 Trauma Centers in the US, across the age and injury spectrum. This study will extend the follow-up period for TRACK-TBI participants. The extensive clinical, imaging, and biomarker data that has already been collected in these TRACK-TBI participants, in combination with the extended longitudinal data, will allow for the identification of risk factors, co-morbidities, and prognostic biomarkers of TBI. Consequently, the extension of study follow-up will help to determine negative neurological and psychological outcomes of individuals who experienced a TBI compared to healthy and orthopedic controls.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telephone Assessment Battery | – | Behavioral: Telephone Outcome AssessmentTRACK-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) | – | Behavioral: In-Person Outcome Assessment, Procedure: 3T Magnetic Resonance Imaging (MRI), Behavioral: Clinical Visit, Procedure: Blood Draw, Procedure: EEGParticipants 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) | – | Behavioral: In-Person Outcome Assessment, Procedure: 3T Magnetic Resonance Imaging (MRI), Behavioral: Clinical Visit, Procedure: Blood Draw, Procedure: EEGParticipants 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 | – | Behavioral: In-Person Outcome Assessment, Procedure: 3T Magnetic Resonance Imaging (MRI), Procedure: Blood DrawParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants enrolled in TRACK-TBI who screen positive for PTE or participants enrolled in TED Friend Controls cohort
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Epilepsy diagnosed prior to index TBI
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 |
|---|---|---|
| In-Person Outcome AssessmentAssessments will be administered to evaluate participant outcome status | Behavioural | Abbreviated Assessment Battery (AAB), Comprehensive Assessment Battery (CAB), TED Friend Controls |
| 3T Magnetic Resonance Imaging (MRI)Participants will be asked to complete a 3T MRI | Procedure or surgery | Abbreviated Assessment Battery (AAB), Comprehensive Assessment Battery (CAB), TED Friend Controls |
| Clinical VisitPatients who screen positive for PTE will have an in-depth clinical visit | Behavioural | Abbreviated Assessment Battery (AAB), Comprehensive Assessment Battery (CAB) |
| Blood DrawBlood Draw for Plasma, DNA, Serum, RNA | Procedure or surgery | Abbreviated Assessment Battery (AAB), Comprehensive Assessment Battery (CAB), TED Friend Controls |
| EEGAn EEG will be performed on patients who screen positive for PTE at the clinical visit | Procedure or surgery | Abbreviated Assessment Battery (AAB), Comprehensive Assessment Battery (CAB) |
| Telephone Outcome AssessmentAssessments will be administered over the telephone to evaluate participant outcome status and screen for PTE | Behavioural | Telephone Assessment Battery |
Primary outcome
Glasgow Outcome Scale Extended (GOSE)
Time frame: 4-6 years after TRACK-TBI enrollment
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.
Diagnostic Interview for Seizure Classification Outside of Video EEG Recording (DISCOVER)
Time frame: 4-6 years after TRACK-TBI enrollment
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
1 secondary outcome
Serum NF-L (neurofilament light chain)
Time frame: 4-6 years after TRACK-TBI enrollment
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 6 Nov 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Post-traumatic Epilepsy, run by University of Pennsylvania at 9 sites 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 8 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale Extended (GOSE) (time frame: 4-6 years after TRACK-TBI enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.