SBIR Phase I: A Novel, Protective Shield to Increase Safety and Efficacy of rTMS Depression Treatment

这个小企业创新研究（SBIR）项目的更广泛的影响/商业潜力是使所有患者都能获得抑郁症的非药物治疗。据世界卫生组织统计，全球有3.5亿人患有抑郁症。在美国，抑郁症影响着1600万人，每年在生产力损失和与该疾病相关的疾病的治疗上花费2100亿美元。抗抑郁药物伴随着负面的副作用，并且在30%的病例中无效。重复经颅磁刺激（rTMS）是FDA批准的一种用于抑郁症治疗的非侵入性方法，包括对患者施加短电磁脉冲。刺激与情绪控制有关的大脑区域。这个SBIR一期项目将帮助产生一种新的rTMS系统，通过刺激更深的脑细胞和减少与当前rTMS治疗相关的疼痛和不适的发生率来改善抑郁症治疗的结果。这种新设备将使基于rTMS的治疗在专业临床医生和未来的家庭护理环境中得到广泛应用。这将避免抑郁症患者对药物的依赖，减少抑郁症对社会的影响。SBIR一期项目建议开发并演示一种新的可穿戴rTMS刺激装置的功效。虽然rTMS对抑郁症患者有75%的成功率，但40%的受试者在使用当前rTMS系统治疗期间报告疼痛，头痛和不适，导致高辍学率。这主要是由于商用rTMS设备的电磁脉冲定位不佳。新系统将结合一种刺激大脑的新技术。在与抑郁有关的最深区域，以前所未有的精确度和一种新的保护罩设计，以防止不必要的热量远离头部，减少头皮疼痛和不适。该项目将开发和验证这些组件的功效，并将其集成到可穿戴头盔中。该项目还将展示新设备相对于当前金标准rTMS解决方案的优越性。该公司预计，这项研究将导致一种新的设备的产生，这种设备能够通过精确的刺激来治疗抑郁症患者，减少40%以上的不必要的热量，从而防止头痛和头皮不适。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is to make non-pharmacological treatment of depression accessible to all patients. According to the World Health Organization, 350 million individuals are affected by depression. In the United States, depression affects 16 million people and it costs $210 billion a year in lost productivity and care for the illnesses related to the disease. Antidepressant drugs are coupled with negative side effects and they are ineffective in 30% of the cases. Repetitive Transcranial Magnetic Stimulation (rTMS) is an FDA approved non-invasive method for depression therapy that consists in the administration of short electromagnetic pulses on patient?s scalp to stimulate regions of the brain involved in mood control. This SBIR Phase I project will help the generation of a new rTMS system that will improve outcomes of depression treatment by stimulating deeper brain cells and reducing the incidence of pain and discomfort associated with current rTMS therapy. The new device will allow broad distribution of rTMS based therapy for both professional clinicians and, in the future, home-care settings. It will avoid reliance on drugs to people affected by depression and it will reduce the impact of depression on society.The SBIR Phase I project proposes to develop and demonstrate the efficacy a new wearable rTMS stimulator device. Although rTMS has a 75% success ratio on depressed patients, 40% of subjects report pain, headaches and discomfort during therapy with current rTMS systems, resulting in a high dropout rate. This is mainly due to poor localization of electromagnetic pulses with commercially available rTMS devices. The new system will combine a new technology that stimulates the brain?s deepest regions involved in depression with unprecedented precision and a new protective shield designed to ward off unwanted heat away from the head, reducing scalp pain and discomfort. The project will develop and validate the efficacy of these components and their integration into a wearable helmet. The project will also demonstrate the superiority of the new device over current gold standard rTMS solutions. The company expects that this research will lead to the generation of a new device capable of treating depression patients through precise stimulation reducing over 40% the unwanted heat, thereby preventing headache and scalp discomfort.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.