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Active Not Recruiting
NCT05823766
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Conditions: Traumatic Brain Injury, Post-traumatic Epilepsy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 300
Sponsor: University of Pennsylvania
Location: University of California, San Francisco San Francisco California
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.
Eligibility Criteria
Inclusion Criteria:
Cohort TBI subjects with PTE
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:
1\. Epilepsy diagnosed prior to index TBI
Source: ClinicalTrials.gov (NCT05823766). StuddyBuddy aggregates publicly available trial information.