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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05823766). StuddyBuddy aggregates publicly available trial information.