Neurotargeting, LLC proposes to develop the technical support infrastructure as well as clinical tools for a commercial software product that will provide a global service for the medical community involved in deep brain stimulator (DBS) therapy. Specifically, this Phase I study will explore the use of a physiological atlas database that can interface with a number of institutions performing DBS implants and programming. The computer algorithms that allow for patient specific MRI and CT data as well as any and all physiological data to become integrated into a HIPAA compliant relational database has been initially developed and tested at Vanderbilt University over the past several years. It has changed the efficiency and thought process of DBS implantation in management profoundly at our institution. Although we have tested this within the DBS clinical and surgical group at Vanderbilt, the value of this universal atlas needs to be explored with several other centers which perform and manage DBS implants in diverse ways. This proposal is a logical step in moving towards a commercially available product and service that addresses the needs of the larger DBS community to facilitate data storage and retrieval from a population based atlas. Its purpose is to provide a universal platform to review patient specific information in the context of the DBS population at large so as to improve surgical implant targeting and post-implant programming efficiency. To date there is no other universal tool that meets this need.
Public Health Relevance: A universal atlas database (Cranial Vault) with software interface (CRAVE) is novel and has global relevance to clinicians, patients, and industry involved with deep brain stimulator (DBS) implants. It is already successfully transforming the surgery and management of DBS implants at one major medical center (Vanderbilt University). Completion of this project will test the ability of the atlas to interface and be useful for all centers that implant and manage DBS therapy in patients.
Public Health Relevance Statement: Project Narrative. A universal atlas database (Cranial Vault) with software interface (CRAVE) is novel and has global relevance to clinicians, patients, and industry involved with deep brain stimulator (DBS) implants. It is already successfully transforming the surgery and management of DBS implants at one major medical center (Vanderbilt University). Completion of this project will test the ability of the atlas to interface and be useful for all centers that implant and manage DBS therapy in patients.
Project Terms: Address; Algorithms; Atlases; Blinded; Brain; Cataloging; Catalogs; Cephalic; Clinical; Clinical Data; Clinical Trials, Phase I; Communities; Computer Programs; Computer software; Computers; Cranial; Data; Data Banks; Data Bases; Data Storage and Retrieval; Databank, Electronic; Databanks; Database, Electronic; Databases; Decision Making; Deep Brain Stimulation; Development; Early-Stage Clinical Trials; Efficiency, Program; Encephalon; Encephalons; Enrollment; Equipment; Ethics Committees, Research; Frequencies (time pattern); Frequency; Future; Goals; Grant; HIPAA; Health Insurance Portability and Accountability Act; IRBs; Image; Implant; Industry; Infrastructure; Institution; Institutional Review Boards; Kennedy Kassebaum Act; Lead; Letters; Location; Logistics; MR Imaging; MR Tomography; MRI; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; Manuals; Medical; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Medical center; Methods; NMR Imaging; NMR Tomography; Nature; Nervous System, Brain; Neurologist; Nuclear Magnetic Resonance Imaging; Operation; Operative Procedures; Operative Surgical Procedures; Outcome; Outcome Assessment (Health Care); Outcomes Assessment; PL 104-191; PL104-191; Patients; Pb element; Phase; Phase 1 Clinical Trials; Phase I Clinical Trials; Phase I Study; Physiologic; Physiological; Population; Process; Program Efficiency; Programs (PT); Programs [Publication Type]; Public Law 104-191; Research; Research Ethics Committees; Research Infrastructure; Research Resources; Resources; Retrieval; Secure; Services; Site; Software; Surgeon; Surgical; Surgical Interventions; Surgical Procedure; System; System, LOINC Axis 4; Technology; Testing; Time; United States Health Insurance Portability and Accountability Act; Universities; Zeugmatography; base; clinical data repository; clinical data warehouse; commercialization; computer program/software; craving; data repository; data retrieval; data storage; deep brain stimulator; enroll; experience; heavy metal Pb; heavy metal lead; imaging; implantation; improved; meetings; novel; phase 1 study; phase 1 trial; phase I trial; population based; programs; protocol, phase I; public health relevance; relational database; response; surgery; tool; vector
