Traumatic Brain Injury Clinical Trial
Official title:
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Verified date | April 2024 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | February 2027 |
Est. primary completion date | February 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas at Austin | Austin | Texas |
United States | Spaulding Rehabilitation Hospital | Charlestown | Massachusetts |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | University of Texas Southwestern | Dallas | Texas |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Pennsylvania/Penn Presbyterian Medical Center | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | University of California, San Francisco | San Francisco | California |
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4-6 years after TRACK-TBI enrollment | |
Primary | 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 | 4-6 years after TRACK-TBI enrollment | |
Secondary | 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). | 4-6 years after TRACK-TBI enrollment |
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