September 16, 2009 NLC INjury and TRaumatic STress Consortium Neuroimaging Leadership Core Lead Investigators: Martha Shenton, BWH Ron Kikinis, BWH Bruce Rosen, MGH NLC

September 16, 2009 NLC Agenda Meeting Objectives Pick Initial Imaging Sites Develop Test Sequences: Structural, DTI, SWI Agenda INTRuST - Overview Neuroimaging Leadership Core - Overview 5 Month Outlook Review Scanners/Develop Sequences Assign Next Actions Other (i.e. Website; T-Con)

September 16, 2009 NLC Mission Develop and evaluate interventions to improve the quality of life of those impacted by PTSD/TBI Design a series of innovative coordinated clinical trials characterized by: State-of-the-art methodology in prevention, detection and treatment Advanced translational research that will inform future therapies Specific focus on service members 10 Sites, 1 Clinical Coordinating Center (CCCC) – Uniform Data and Imaging Set Approved Projects Proof of Concept Trial of Ganaxolone in PTSD Brain Indices of Risk for PTSD after Mild TBI Randomized Controlled Trial of Atomoxetine, Methylphenidate and Placebo in PTSD with or without mTBI The Effect of Telephone Follow-up on Outcome for Military Personnel with mild TBI/PTSD Randomized Clinical Trial of Glyburide for TBI INTRuST - Overview

September 16, 2009 NLC Neuroimaging Leadership Core INTRuST- Structure 10 Consortium Members Dartmouth College Duke University The Geneva Foundation (not participating in imaging) Henry M. Jackson Foundation South Carolina Research Authority Spaulding Research Administration UCSD Surgery University of Cincinnati University of Maryland University of Washington CCCC - UCSD Director : Murray Stein, M.D.

September 16, 2009 NLC Personnel for Leadership Core PIs: BWH: Martha Shenton, Ron Kikinis MGH: Bruce Rosen Personnel: MGH: Karl Helmer, Randy Gollub, Bruce Fischl, Andre Van Der Kouwe Roger Pitman BWH: Carl-Fredrik Westin, Sylvain Bouix Marek Kubicki, Jorge Alvarado, Rayna Zacks WU:Dan Marcus SPD: Ross Zafonte

September 16, 2009 NLC Specific NLC Goals NLC Mission Provide leadership, coordination, quality control and management of all MR data acquisition, transfer storage for INTRuST clinical trials Use imaging protocols that do not require research agreements between site and relevant vendors. Optimize and standardize imaging protocols across imaging platforms, and install and test specific MR sequences across sites that use different vendors. Perform Automated and Manual Quality Control of images particularly after hardware upgrade. Data transfer, security, and access

September 16, 2009 NLC Identify Acquisition Sequences Review Sites for Suitability for Imaging Structural, Diffusion, and Susceptibility- Weighted Images Review Sites for Suitability for Imaging Structural, Diffusion, and Susceptibility- Weighted Images FEEDBACK Collect Data on 3 Subjects at each potential site, perform Calibration FEEDBACK Collect Data on 3 Subjects at each potential site, perform Calibration Select Consortium Sites for Image Acquisition Structural and DTI protocol parameters Recommended by BIRN SWI protocol Determined by literature Pulse sequence optimization metrices Structural  means and variances of cortical thickness maps subcortical and ventricular structure volumes DTI  Whole-brain and ROI FA maps SWI  SNR/CNR calculated for each imaging volume Additional Measures Profusion/Resting State – 1 Hour

September 16, 2009 NLC Data Transfer, Manual and Automated Quality Control, Data Security, Data Access Data Transfer, Manual and Automated Quality Control, Data Security, Data Access First 1-6 Months Of Year 1 Begin Image Acquisition Month 6 Review Sites for Suitability for Imaging Structural, Diffusion, and Susceptibility-Weighted Images Review Sites for Suitability for Imaging Structural, Diffusion, and Susceptibility-Weighted Images Train Personnel at Selected Sites on Acquisition, Distortion Correction; Collect 5 Subjects Acquired at 2 Time Points FEEDBACK Collect Data on 3 Subjects at each potential site, perform Calibration FEEDBACK Collect Data on 3 Subjects at each potential site, perform Calibration Select Consortium Sites for Image Acquisition FEEDBACK Calibration, Distortion Correction, Establish Norms, Train on Data Transfer FEEDBACK Calibration, Distortion Correction, Establish Norms, Train on Data Transfer Continue To Acquiring Images Years 2-4 Link Neuroimaging Data with Clinical Data in San Diego Work Flow

September 16, 2009 NLC Month 1 and 2 Review/Collect Site Capabilities Month 3 Screen Sites for Initial Eligibility Determine acquisition sequences Month 4 and 5 Protocol Optimization 3 subjects scanned / Site BIRN Phantom Tentative Site Selection Establish Norms 5 subjects scanned twice Hard/software changes Final Site Selection Review Sites for Suitability for Imaging Structural, Diffusion, and Susceptibility- Weighted Images Review Sites for Suitability for Imaging Structural, Diffusion, and Susceptibility- Weighted Images Train Personnel at Selected Sites on Acquisition, Distortion Correction; Collect 5 Subjects Acquired at 2 Time Points FEEDBACK Collect Data on 3 Subjects at each potential site, perform Calibration FEEDBACK Collect Data on 3 Subjects at each potential site, perform Calibration Select Consortium Sites for Image Acquisition FEEDBACK Calibration, Distortion Correction, Establish Norms, Train on Data Transfer FEEDBACK Calibration, Distortion Correction, Establish Norms, Train on Data Transfer 5 Month Outlook

September 16, 2009 NLC Review Scanners Sequence Development Review Scanners Sequence Development

September 16, 2009 NLC Wrap Up Assign Next Actions Notify Sites Finalize Protocol Development IRB Schedule Visits Wiki/Website intrust.spl.harvard.edu “Leadership Core” section Announcements Benchmarks Minutes Archive Calendar T-Con Call September 25, 9:00 AM General INTRuST Overview NLC Overview NLC People ____________ Leadership Core Announcements Benchmarks Minutes Archive Calendar Collaborations _____________ Resources Imaging PTSD/TBI Contact US NLC INTRuST Neuroimaging Leadership Core MISSION STATEMENT HERE