Selective Laser Stimulator of C and A delta fibers

C 和 A delta 纤维的选择性激光刺激器

基本信息

批准号：
7340448
负责人：
Mikhail I. Nemenov
金额：
$ 35.61万
依托单位：
LASMED, LLC
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-20 至 2011-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7340448
关键词：
Affect Agonist Analgesics Benchmarking Burning Pain C Fiber Capsaicin Certification Computer software Development Devices Diagnosis Dimethyl Sulfoxide Drug Evaluation Electroencephalography Evaluation Evoked Potentials Fiber Fibers, A Funding Goals Heating Human Human Volunteers Image Invasive Lasers Magnetism Marketing Measurement Mediating Medical Morphine Neurons Nociceptors Opioid Opioid Analgesics Pain Pain Measurement Pain Threshold Patients Pharmaceutical Preparations Phase Physiologic pulse Protocols documentation Psychophysiology Pulse taking Rattus Safety Skin Skin Tissue Small Business Funding Mechanisms Small Business Innovation Research Grant Solvents Standards of Weights and Measures Stimulus System TRPV1 gene Testing Treatment Efficacy United States Food and Drug Administration prototype response tool volunteer

项目摘要

DESCRIPTION (provided by applicant): The goal of this Phase II SBIR project is to develop and validate an efficient and consistent selective stimulator to assess A-delta and C fiber pain sensing neurons (nociceptors) for use with human volunteers for new drug evaluation and with pain patients to aide in diagnosis. There is currently no commercially available tool of similar capabilities on the market. Evaluation of thermal pain sensitivity in humans can be useful in describing the potential utility of putative analgesic drugs. The ability to reliably, differentiate pain mediated by the activation of unmyelinated (C) or myelinated (A-delta) nociceptors may also provide allow for more accurate prediction of the efficacy of pain treatments. There is also a potential utility of being able to differentially as certain pain mediated by these two afferent types in establishing a diagnosis for, and following the progress of patients in pain. Thus, it is our overall goal to establish stimulation protocols for use with our unique infrared diode laser that will allow, in humans, for the differential assessment of pain evoked by the activation of these two nociceptor types, and to test these protocols using benchmark pharmacologic agent. Thus, we hypothesize that the infrared diode laser will prove safe and reliable, such that it, and its components will be certifiable for meeting FDA requirements for non-invasive skin heating. To do this, we will determine the stimulus intensity margin between pain threshold measurement and skin damage. In addition, we will insure complete compatibility of the laser with functional magneto-resonance imaging systems and EEG cortical evoked potential recording systems, making any hardware and software adjustments that are necessary. We will also submit the laser and its components for certification as to electrical and magnetic interference and for medical laser safety standards, and make any device changes that are necessary to meet the requirements. We will also insure that the device protocols will allow for accurate and differential assessment of proalgesic and analgesic effects of drugs known to differentially affect C or A-delta nociceptors, including the TRPV1 agonist capsaicin, the A-delta sensitizing solvent dimethyl sulfoxide (DMSO), and the mu opioid analgesic morphine. To do this, we will assess psychophysical and cortical (EEG) responses evoked by brief pulses that activate A-delta nociceptors, or longer pulses that activate C fiber nociceptors.

描述（由申请人提供）：该II阶段SBIR项目的目标是开发和验证一个有效，一致的选择性刺激器，以评估A-DELTA和C纤维疼痛感应神经元（Nocieptors），以与人类志愿者一起用于新药物评估和新药。疼痛患者诊断助手。目前，市场上没有类似能力的市售工具。评估人类热疼痛敏感性对于描述假定镇痛药的潜在效用可能是有用的。可靠地，区分疼痛的能力是通过非髓鞘（C）或髓鞘（A-Delta）伤害感受器的激活所介导的，也可以使得更准确地预测疼痛治疗的功效。在建立疼痛患者的诊断和跟随患者进展的情况下，这两种传入类型介导的某些疼痛介导的某些疼痛也有潜在的实用性。因此，我们的总体目标是建立与我们独特的红外二极管激光器一起使用的刺激方案，这将允许在人类中，通过激活这两种伤害感受器类型的激活引起的疼痛的差异评估，并使用基准药物学测试这些方案代理人。因此，我们假设红外二极管激光器将被证明是安全可靠的，因此它的组件及其组件将是满足非侵入性皮肤加热需求的认证。为此，我们将确定疼痛阈值测量和皮肤损伤之间的刺激强度缘。此外，我们还将确保激光与功能性磁谐成像系统和EEG皮层诱发潜在记录系统的完全兼容性，从而对任何必要的硬件和软件调整进行任何硬件和软件调整。我们还将提交激光及其组件以进行电气和磁干扰以及医疗激光安全标准，并进行满足要求所需的任何设备。我们还将确保设备方案将允许对已知的差异化药物的促和镇痛作用进行准确和差异评估，从而影响C或A-DELTA伤害感受器，包括TRPV1激动剂Capsaicin，A-delta敏感性的二甲基硫氧化二甲基硫代（DMSO）A-delta敏感性和MU阿片类镇痛吗啡。为此，我们将通过简短的脉冲激活A-Delta伤害感受器或更长的脉冲来评估心理物理和皮质（EEG）反应，或激活C纤维伤害感受器的脉冲。