BOOST-3 Study Update: Enrollment Progress, Ancillary Studies, and Epileptogenesis Project
Stay updated on the BOOST-3 study led by Dr. Ramon Diaz-Arrastia, including enrollment status, delays, and ancillary studies like BioBOOST and ELECTROBOOST. Explore the latest developments in the research on traumatic brain injury and epilepsy.
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Presentation Transcript
Virtual Investigators Meeting Virtual Investigators Meeting January 14, 2021 January 14, 2021 Ramon Diaz-Arrastia, MD, PhD Professor of Neurology, University of Pennsylvania BOOST-3 Study Chair
Enrollment to Date Enrollment to Date n = 114 Sites with enrollment = 20 Sites released to enroll = 34
Enrollment delays Enrollment delays Most sites were closed for COVID19 Many have reopened over time with 4 still closed Site opening slower than anticipated Delays in approval by cIRB First multicenter trial to use a cIRB for EFIC Difficulties performing EFIC activities with COVID19 All sites should be cIRB approved and open by early 2021
BOOST3 Ancillary Studies BioBOOST Blood and CSF biomarkers of CNS injury Funded by DoD (BA170613, Award W81XWH-19-1-0829) Separate consent not under EFIC Approved by DSMB and cIRB 5 sites have ceded IRB approval Approved by DoD Human Research Protection Office (HRPO) Subcontracts in progress with clinical sites Protocol, Manual of Procedures, and CRFs finalized Investigators Meeting by video-conference on 10/8 and 10/12 3 sites currently open for enrollment Anticipate first enrollment during January 2020
BOOST3 Ancillary Studies ELECTROBOOST Prospective observational study at 18 sites that utilize cEEG as standard of care in severe TBI (n=200) PIs: Emily Gilmore (contact, Yale), Eric Rosenthal (MGH), Kan Ding (UTSW) Specific Aims Demonstrate effects of electrographic seizures (eSz) and high-frequency periodic discharges (HF-PD) on brain oxygenation Quantify the effects of eSz and HF-PD on functional outcome Investigate the impact of AED escalation on eSz and HF-PD exposure Separate consent waived Approved by NINDS Council; NGA 7/31/2020 (R01 NS117904) Protocol and MOP Finalized; CRFs in final stages of development Anticipate first enrollment Q1 2021
BOOST Epileptogenesis Project Prospective observational study of BOOST-3 and ELECTRO-BOOST participants (n = 200) Extend FU to 2 years after injury MRI at 6 months after injury Participants who screen positive on telephone interview for possible post-traumatic epilepsy will be invited for an in-person evaluation with expert epileptologist Gold standard DISCOVER interview to adjudicate PTE Hypotheses designed to asses electrophysiologic, imaging, and molecular biomarkers associated with PTE Submitted to DoD 7/21/2020. Scored 1.6 (Not selected for funding) Planned re-submission to NIH or DoD
