AN41--Pre-clinical Research: Behavioral Assessment

This is a Special Notice of intent to award to an affiliate vendor. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a requirement of Traumatic Brain Injury and Posttraumatic Stress Disorder (PTSD) research services for the White River Junction Healthcare System, VT. The applicable NAICS code is 541715. The PSC/FSC is AN41. The authority for this action is FAR 13.106-1(b): Soliciting from a single source and fulfills FAR Part 5.101(a) posting requirements. This is a Pre-Solicitation notice synopsizing a potential RFQ solicitation to satisfy the requirements of FAR 5.201 and 5.203. All interested parties should register via SAM.gov interested vendors list. It is the responsibility of the offeror to monitor and download amendments from SAM.gov Contract Opportunities, which may be issued to this solicitation. In accordance with FAR 52.204-7, FAR 2.101, and VAAR 802.101, prospective firms must be registered in SAM (www.sam.gov), and in VetCert (Veteran Small Business Certification (sba.gov)) databases prior to award. ((Note: In accordance with Public Law 109-461, 38 USC 8127, and NDAA 2021, all vendors claiming Small Business status in accordance with the Veteran's First Contracting Program must be VERIFIED by the Small Business Administration (SBA)). Also, to qualify for a VA contract, vendor must be vendorized by completing Form 10091 at URL https://www.cep.fsc.va.gov/ . Interested persons may contact the Contracting Specialist via email at Ophelia.Wilson@va.gov regarding this procurement. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer PERFORMANCE WORK STATEMENT Personalized Interventions for Traumatic Brain Injury and Posttraumatic Stress Disorder (PTSD) INTRODUCTION: The mission of VA s National Center for PTSD (NCPTSD) is to advance the clinical care and social welfare of America's Veterans and others who have experienced trauma, or who suffer from PTSD, through research, education, and training in the science, diagnosis, and treatment of PTSD and stress-related disorders. We generate, collate, synthesize, disseminate, and promote implementation of the best information about PTSD. SCOPE: Traumatic brain injury (TBI) and PTSD are significant problems for Veterans and can lead to neuropsychiatric symptoms that pose extensive quality of life burdens on affected individuals. These conditions share similar pathology, and thus, there is a growing interest in developing treatments that target shared mechanisms. Disrupted communication between brain regions is one mechanism thought to perpetuate symptomatology. To guide personalized interventions, there is a critical need to define neural signatures that are associated with behavioral domains of impairment and response to treatment. Using models, the current project will evaluate neural signatures and behavioral deficits following exposure to neurotrauma or psychological trauma. Targeted treatment (brain stimulation, pharmacotherapy, or combination) will then be administered to improve outcomes. The proposed work supports ongoing collaborative research conducted by investigators at the White River Junction VA. Key activities to be performed include: 1) Define behavioral deficits, 2) Define neural signatures, and 3) Define treatment outcomes. PERIOD AND PLACE OF PERFORMANCE: This contract anticipates service utilization that will occur over the course of five years. The place of performance will be at both the White River Junction VA Healthcare System (WRJ-VAHS) and the contractor location, Mary Hitchcock Memorial Hospital for itself and on behalf of Dartmouth-Hitchcock Clinic (MHMH/DHC). Approximately 25% of the work will be performed at the WRJ-VAHS, and the other 75% of work will be performed in Dr. Wilder Doucette s laboratory at MHMH/DHC. The contract location is located within a 30-minute drive of the WRJ facility to ease transportation of the subjects. It has been determined that transportation can be feasibility performed, due to shared veterinary resource agreement between locations. PROJECT MANAGEMENT AND STAFFING: Wilder Doucette, MD, PhD (Project Lead). Dr. Doucette is a Research Affiliate (WOC) at the WRJ-VAHS and Assistant Professor of Psychiatry and Program Director of the Psychiatry Residency Research Track at the Geisel School of Medicine. His research focuses on the systems-level neural activity underpinnings of behavior and how neuromodulation-based treatments alter this activity and improve dysfunction. His research-informed, part-time clinical practice focuses on interventional and addiction psychiatry, and he has extensive experience with pre-clinical models of neuropsychiatric deficits. Dr. Doucette has experience with pre-clinical interventions, including brain stimulation and targeted pharmacotherapy, and using assays to define neurobehavioral deficits in clinically relevant models of psychiatric illness. Dr. Doucette will be responsible for overseeing the behavioral assessments, treatment, and brain activity recording for the current project. Dr. Doucette will be involved in data analyses, interpretation of findings and helping to prepare results for dissemination and publication. Elise Bragg, BS, RLATG, Senior Research Associate (WOC). Mrs. Bragg is Dr. Doucette s Lab Manager at MHMH/DHC. She has extensive pre-clinical experience, including neuromodulation and performing neurobehavioral assessments in subjects, and holds a Registered Laboratory Technologist (RLATG) designation by the American Association for Laboratory Animal Science (AALAS). Mrs. Bragg will be responsible for the stress induction, behavioral assays, treatment, and electrophysiologic measures proposed in the current study and overseeing the preparation of study subjects for surgery. TBD, graduate Student(s). Dr. Doucette s lab is a training site for various undergraduate, graduate, and medical students, as well as post-doctoral fellows. Under Dr. Doucette and Mrs. Bragg s mentorship and oversight, students will assist with pre- and post-operative care, stress and injury induction, and behavioral testing. Additionally, they will provide data entry and other administrative support to the project. BACKGROUND: The WRJ Translational Neuroscience Research Group aims to identify and evaluate novel interventions for TBI and PTSD. Using models, the current project aims to determine how targeted treatment can be used to alter behavioral deficits associated with neurotrauma and psychological trauma. Validated pre-clinical behavioral assays will be used to assess impairment. Brain stimulation will be delivered via customized electrodes targeting clinically relevant brain regions, and pharmacotherapy will be administered to target underlying mechanisms of brain stimulation or enhance treatment response. Neural activity biomarkers will be collected to assess how systems-level brain activity relates to behavioral deficits and response to treatment. Subjects will be assessed at various time points throughout the study. PERFORMANCE OBJECTIVES/DELIVERY SCHEDULE: Define behavioral deficits associated with neurotrauma or trauma exposure (deliver data set and report within 6 months of contract start date). Determine the utility of neural activity biomarkers to identify subjects with behavioral deficits or personalize treatment (deliver data set and report within 6 months of contract start date). Determine the utility of neuromodulation and targeted pharmacotherapy to improve behavioral deficits (deliver data set and report within 9 months of contract start date). Summarize study findings (deliver data set and report within 12 months of contract start date) and there after. Acceptable completion of deliverables will be determined through receipt of complete data sets that include details of all procedures, behavioral outcomes, and statistical comparisons. All deliverables include estimated personnel and supply costs associated with planned studies. OPERATING CONSTRAINTS: Subjects will be randomly assigned to study conditions, which include naïves, TBI/Sham injury, Trauma/Sham exposure, and Active/Sham treatment. Shockwave-induced brain injuries will be administered with a blast tube (ORA, Inc.) located at the WRJ-VAHS according to published protocols. Psychological trauma (PTSD-induction) will be experimentally induced according to published protocols, which include but are not limited to the inescapable shock or single-prolonged stress models. Behavioral assays will be conducted to assess clinically-relevant domains of impairment according to published protocols. Brain stimulation. Custom-built electrode arrays will be implanted using stereotactic surgery targeting brain regions, which include but are not limited to the infralimbic cortex, prelimbic cortex, nucleus accumbens core, and the central nucleus of the amygdala. Pharmacotherapy will be administered to target underlying…