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NCT05823766Active, not recruiting

Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
10 Apr 2023
Start date
1 Mar 2022
Primary completion date
Oct 2026
Lead sponsor
University of Pennsylvania
Diseases
Epilepsy
NCT number
NCT05823766

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From 1 Mar 2022 to the primary completion date, Oct 2026
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 1\. Epilepsy diagnosed prior to index TBI

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Texas at Austin
Coordinator of this site? Confirm its status
AustinUnited StatesUnknown status
Spaulding Rehabilitation Hospital
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CharlestownUnited StatesUnknown status
University of Cincinnati
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CincinnatiUnited StatesUnknown status
University of Texas, Southwestern
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DallasUnited StatesUnknown status
Baylor College of Medicine
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HoustonUnited StatesUnknown status
University of Pennsylvania/Penn Presbyterian Medical Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status
University of Pittsburgh
Coordinator of this site? Confirm its status
PittsburghUnited StatesUnknown status
University of California San Francisco
Coordinator of this site? Confirm its status
San FranciscoUnited StatesUnknown status
University of Washington
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.