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

这个小企业创新研究（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差异如何影响大脑中的电导率，更重要的是，使用经颅直流刺激（tDCS）和经颅磁刺激（TMS）技术实现神经系统疾病的精确治疗。许多研究表明，这些技术可以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、帕金森症和精神分裂症的症状。然而，目前对人类头部电磁（EM）特征的理解，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兴奋通路，以支持特定的临床目标。这可能导致意想不到的，有时无效甚至有害的结果。实现激励技术的模型和TMS/tDCS处理系统没有经过标准验证。彻底了解途径和发展验证模拟和幻影结构将有助于开发和临床实施精确控制的分析模型和协议，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，为临床实施更精确、可量化的tDCS和TMS技术开发可复制的头部幻象。本研究将对固体、液体和凝胶材料进行表征，选择符合生物医学和商业化标准的材料。分析将用于开发材料组合的配方，以解决人类大脑部分和界面的电导率和各向异性的范围。将对这些配方进行实验评估，并对其可生产性和准确性进行改进。这将为第二阶段及以后使用的材料解决方案提供一个数据库。传统的脑电导率模拟物是由单一琼脂基电导率模拟物组成的简单球形外壳，缺乏人脑的复杂性。开发EM脑幻影的挑战包括制造各种材料以控制和可重复的各向异性电导率值，塑造这些材料以模拟解剖特征，并将它们结合起来代表边界界面和控制间隙，以实现准确的通路性能。建议的工作包括开发一个外壳模拟，该模拟包含适用的材料配方，以验证在第二阶段中更复杂的原型模型的可扩展性。

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.