Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI) (NCT05823766)

🧪 Interventions in This Study

• In-Person Outcome Assessment (BEHAVIORAL)
• 3T Magnetic Resonance Imaging (MRI) (PROCEDURE)
• Clinical Visit (BEHAVIORAL)
• Blood Draw (PROCEDURE)
• EEG (PROCEDURE)
• Telephone Outcome Assessment (BEHAVIORAL)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Cohort TBI subjects with PTE
2. 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
3. Must complete at least one Telephone Assessment (and a recruitment phone call)
4. 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
5. 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
6. 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
7. Ability of participant or legally authorized representative to provide informed consent Participation in TED: Friend Controls Study (IRB # 827537)

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (9 Sites)

• University of California, San Francisco — San Francisco, California
• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts
• University of Cincinnati — Cincinnati, Ohio
• University of Pennsylvania/Penn Presbyterian Medical Center — Philadelphia, Pennsylvania
• University of Pittsburgh — Pittsburgh, Pennsylvania
• University of Texas at Austin — Austin, Texas
• University of Texas Southwestern — Dallas, Texas
• Baylor College of Medicine — Houston, Texas
• University of Washington — Seattle, Washington

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Traumatic Brain Injury

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• Cognitive and Vascular Functioning Following TBI — Bethesda, Maryland
• Scale-Up Evaluation Trial of the Diabetes Prevention Program to Improve Obesity and Cardiometabolic Health After Traumatic Brain Injury — Dallas, Texas
• Community-based Implementation of Online EmReg — New York, New York
• Evaluation of the SCALED (SCaling AcceptabLE cDs) — Minneapolis, Minnesota
• Treating Mild Traumatic Brain Injury With High Definition Transcranial Direct Current Stimulation — Dallas, Texas

Explore by condition: All Traumatic Brain Injury clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.