DEVICE AND METHOD FOR BIOMARKERS IN SCHIZOPHRENIA

用于精神分裂症生物标志物的装置和方法

• 批准号: 7536467
• 负责人: GEORGE Z HU
• 金额: $ 25万
• 依托单位: SYNABRIDGE CORPORATION
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-18 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7536467
• 关键词: Adolescent; Adult; Affect; Algorithms; American; American Psychological Association; Applications Grants; Attention; Benchmarking; Biological Markers; Brain region; Calibration; Child; Clinic; Clinical; Cognitive deficits; Communities; Computer software; Condition; Data Analyses; Data Collection; Delusions; Development; Devices; Disease; Dorsal; Early Diagnosis; Electrodes; Electroencephalogram; Evoked Potentials; First Degree Relative; Fourier Transform; Frequencies; Functional disorder; Goals; Hallucinations; Health Professional; Human; Impaired cognition; Individual; Invasive; Link; Location; Marketing; Measurement; Measures; Medical; Medical center; Mental Health; Mental disorders; Methods; Monitor; Morphologic artifacts; NIH Program Announcements; Neural Pathways; Noise; Numbers; Parietal Lobe; Pathway interactions; Patients; Phase; Physiological; Pilot Projects; Population; Procedures; Process; Property; Psychiatrist; Psychiatry; Psychologist; Psychology; Public Health; Purpose; Range; Rate; Research; Resolution; Risk; Sampling; Scalp structure; Schizophrenia; Sensitivity and Specificity; Sensory Process; Severities; Signal Transduction; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Staging; Stimulus; Stream; Subgroup; Surface; Symptoms; System; Techniques; Temporal Lobe; Testing; Treatment Protocols; Universities; Vision; Visual; Visual Pathways; Visual evoked cortical potential; Visual system structure; Withdrawal; base; design; instrument; interest; magnocellular; member; parvocellular; relating to nervous system; response; severe mental illness; size; social; user friendly software; user-friendly; visual process; visual processing; visual stimulus; Adolescent; Adult; Affect; Algorithms; American; American Psychological Association; Applications Grants; Attention; Benchmarking; Biological Markers; Brain region; Calibration; Child; Clinic; Clinical; Cognitive deficits; Communities; Computer software; Condition; Data Analyses; Data Collection; Delusions; Development; Devices; Disease; Dorsal; Early Diagnosis; Electrodes; Electroencephalogram; Evoked Potentials; First Degree Relative; Fourier Transform; Frequencies; Functional disorder; Goals; Hallucinations; Health Professional; Human; Impaired cognition; Individual; Invasive; Link; Location; Marketing; Measurement; Measures; Medical; Medical center; Mental Health; Mental disorders; Methods; Monitor; Morphologic artifacts; NIH Program Announcements; Neural Pathways; Noise; Numbers; Parietal Lobe; Pathway interactions; Patients; Phase; Physiological; Pilot Projects; Population; Procedures; Process; Property; Psychiatrist; Psychiatry; Psychologist; Psychology; Public Health; Purpose; Range; Rate; Research; Resolution; Risk; Sampling; Scalp structure; Schizophrenia; Sensitivity and Specificity; Sensory Process; Severities; Signal Transduction; Site; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Staging; Stimulus; Stream; Subgroup; Surface; Symptoms; System; Techniques; Temporal Lobe; Testing; Treatment Protocols; Universities; Vision; Visual; Visual Pathways; Visual evoked cortical potential; Visual system structure; Withdrawal; base; design; instrument; interest; magnocellular; member; parvocellular; relating to nervous system; response; severe mental illness; size; social; user friendly software; user-friendly; visual process; visual processing; visual stimulus

DESCRIPTION (provided by applicant): This Phase I SBIR grant application is in response to the Program Announcement for Development of Biomarkers for Mental Health Research. The goal of the proposed project is to develop a non-invasive electrophysiological device that will provide a biomarker for schizophrenia, which is a severe, heterogeneous mental disorder that leads to hallucinations and delusions, social withdrawal, and cognitive decline. While higher cognitive deficits have received a great deal of attention in schizophrenia research, a growing number of studies reveal deficits in early stages of visual processing. In particular, prominent deficits have been found in the magnocellular pathway, which conducts low-resolution spatial information rapidly to cortex and is involved in overall stimulus organization. Visual deficits are linked to higher-level functions, and visual function can be examined by obtaining electrophysiological recordings from surface electrodes placed on the scalp while specific stimuli are presented. These techniques have confirmed visual pathway dysfunction in schizophrenia. The ultimate goal of this project is to design a marketable medical instrument that can be used in clinical locations for the purposes of early detection of schizophrenia, identification of subgroups, indicating changes in severity, and monitoring of treatment regimens. This has clear implications for identification and treatment of a major psychiatric disorder. Currently, there is no electrophysiological device commercially available that contains prepackaged, automated stimulus paradigms and analysis techniques to assess visual function. The specific aims are to: 1) Develop user-friendly, automated hardware and software for precisely calibrated delivery of visual stimuli, based on specific sensory processing deficits in schizophrenia; 2) Build a device that is capable of recording electrophysiological responses from different brain regions in order to probe visual activity in each neural pathway and mechanism of interest and that decreases contamination from extraneous electrical signals, which is expected to increase sensitivity and specificity of the biomarker measures; 3) Develop user-friendly software for data analysis to enable automated rejection of corrupted signals and objective quantification of electrophysiological responses; 4) Apply the developed instrument in a pilot study of patients with schizophrenia and controls to identify a subset of critical test conditions which will be refined in a Phase II project to establish a composite VEP measure to serve as an efficacious biomarker. PUBLIC HEALTH RELEVANCE: Schizophrenia is a severe mental illness affecting 1% of the population. The goal of this Phase I SBIR application is to develop a user-friendly device that measures electrophysiological activity in the visual system, which has been shown to be profoundly impaired in schizophrenia. Of relevance to public health, this device is expected to provide a biomarker for this disorder and the ultimate goal is for it to be used in clinical settings for early detection of schizophrenia and monitoring of treatment regimens.

描述（由申请人提供）：此I阶段SBIR赠款的应用是响应针对心理健康研究生物标志物开发的计划公告。拟议项目的目的是开发一种非侵入性电生理设备，该设备将为精神分裂症提供生物标志物，这是一种严重的，异质的精神障碍，导致幻觉和妄想，社交戒断和认知能力下降。虽然较高的认知缺陷在精神分裂症研究中引起了很多关注，但越来越多的研究表明，在视觉处理的早期阶段缺陷。特别是，在大细胞途径中发现了显着缺陷，该途径迅速向皮层进行低分辨率空间信息，并参与整体刺激组织。视觉缺陷与更高级别的功能有关，可以通过从放置在头皮上的表面电极获得电生理记录来检查视觉功能，同时提出了特定的刺激。这些技术已经证实了精神分裂症的视觉途径功能障碍。该项目的最终目的是设计一种可销售的医疗工具，该工具可用于临床位置，目的是为了早期发现精神分裂症，鉴定亚组，表明严重程度的变化和治疗方案的监测。这对重大精神疾病的识别和治疗具有明显的影响。当前，尚无市售的电生理设备，其中包含预先包装的，自动化的刺激范式和分析技术来评估视觉功能。具体目的是：1）基于精神分裂症的特定感觉处理缺陷，开发了用户友好，自动化的硬件和软件，以精确校准视觉刺激的交付； 2）构建一种能够记录来自不同大脑区域的电生理反应的设备，以探测每种神经途径和感兴趣机制的视觉活动，并从外部电信号中降低污染，这预计会增加生物标志物测量的敏感性和特异性； 3）开发用于数据分析的用户友好软件，以实现对损坏信号的自动拒绝和电生理响应的客观量化； 4）将开发的仪器应用于精神分裂症患者和对照组的试点研究中，以确定一部分关键测试条件，这些测试条件将在II期项目中进行完善，以建立复合VEP测量，以作为有效的生物标志物。公共卫生相关性：精神分裂症是一种严重的精神疾病，影响1％的人群。该阶段I SBIR应用的目的是开发一种用户友好的设备，该设备测量视觉系统中的电生理活动，该设备已被证明在精神分裂症中受到了严重损害。与公共卫生相关的是，该设备有望为这种疾病提供生物标志物，最终目标是将其用于临床环境中，以早日检测精神分裂症和监测治疗方案。