SBIR Phase I: Phantom Head for Testing and Standardizing Transcranial Magnetic and Direct Current Stimulation Therapies

这个小型企业创新研究（SBIR）第一阶段项目的更广泛的影响/商业潜力是了解患者之间的解剖变异性如何影响大脑的电导率，更重要的是，使用经颅直流电刺激（tDCS）和经颅磁刺激（TMS）技术精确治疗神经系统疾病。许多研究表明，这些技术可以经济有效地用于改善学习，工作记忆，以及缓解慢性疼痛和抑郁症，纤维肌痛，帕金森氏症和精神分裂症的症状。然而，目前对人类头部的电磁（EM）特性的理解以及最先进的TMS和tDCS技术都无法精确控制大脑中最合适的激励通路以支持指定的临床目标。这可能会导致意想不到的，有时无效甚至有害的结果。用于实施励磁技术的模型和TMS/tDCS处理系统未按照标准进行验证。 对路径的透彻理解和有效模拟物和体模结构的开发将使精确控制的分析模型和协议的开发和临床实施成为可能，以实现有效，广泛可及，可靠和安全的TMS/tDCS治疗。拟议的项目将解决当前颅内电磁特性和材料性能知识的空白，以开发可重复的头部体模，用于临床实施更精确，tDCS和TMS技术。这项研究将表征选择的固体，液体和凝胶材料，以符合生物医学和商业化标准。分析将用于开发材料组合的配方，以解决人脑部分和界面的导电性和各向异性的范围。将对这些配方进行实验评估，并对生产率和准确度进行改进。 这将提供一个材料解决方案的数据库，将用于第二阶段及以后。 传统的脑电导率模拟物是由单一基于琼脂的电导率模拟物组成的简单球形壳，其缺乏人脑的复杂性。开发EM脑体模的挑战包括制造用于受控和可再现的各向异性电导率值的各种材料，使这些材料成形以模拟解剖特征，并将它们组合以表示边界界面和控制间隙以实现准确的通路性能。拟议的努力包括开发一个壳模拟，采用适用的材料配方，以验证可扩展性，更复杂的原型幻影在第二阶段。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to understand how conductivity in the brain is affected by anatomical variability between patients and, more importantly, to enable precise treatment of neurological diseases using transcranial Direct Current Stimulation (tDCS) and Transcranial Magnetic Stimulation (TMS) techniques. A number of studies have shown these techniques may be used, cost-effectively, to improve learning, working memory, as well as relieve chronic pain and the symptoms of depression, fibromyalgia, Parkinson's, and schizophrenia. However, current understanding of electromagnetic (EM) characteristics for the human head and state-of-the-art TMS and tDCS techniques suffer from the inability to precisely control the most appropriate excitation pathways in the brain to support a specified clinical objective. This can result in unexpected and sometimes ineffective or even detrimental outcomes. Models and TMS/tDCS treatment systems for implementation of excitation techniques are not validated to standards. A thorough understanding of pathways and development of validated mimics and phantom structures will enable development and clinical implementation of precisely controlled analytical models and protocols for effective, widely accessible, reliable and safe TMS/tDCS treatments.The proposed project will address gaps in current knowledge of intracranial electromagnetic characteristics and materials performance to develop reproducible head phantoms for clinical implementation of more precise, quantifiable tDCS and TMS techniques. This research will characterize solid, liquid and gel materials selected to comply with biomedical and commercialization criteria. Analyses will be used to develop formulations of combinations of materials that address the range of conductivity and anisotropy of the parts and interfaces of the human brain. These formulations will be experimentally evaluated and refined for producibility and accuracy. This will provide a database of materials solutions which will be used in Phase II and beyond. Traditional brain conductivity mimics are simple spherical shells consisting of a single agar based conductivity mimic, which lacks the complexity of the human brain. The challenges of developing an EM brain phantom include fabrication of the various materials for controlled and reproducible anisotropic conductivity values, shaping these materials to mimic anatomical features, and combining them to represent boundary interfaces and control gaps for accurate pathway performance. The proposed effort includes development of a shell mimic that incorporates applicable material formulations to validate extensibility to more sophisticated prototype phantoms during Phase II.