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

SBIR 第一阶段：一种新颖的保护罩，可提高 rTMS 抑郁症治疗的安全性和有效性

• 批准号: 1820005
• 负责人: Hsiu Huang
• 金额: $ 22.49万
• 依托单位: NeuroPrex Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-07-15 至 2019-05-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1820005&HistoricalAwards=false
• 关键词: SBIR; Phase; Novel; Protective; Shield

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.

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，每年因生产力损失和与疾病相关的疾病护理而损失2100亿美元。抗抑郁药伴随着负面副作用，在30%的病例中无效。重复经颅磁刺激（rTMS）是FDA批准的非侵入性抑郁症治疗方法，包括对患者的短电磁脉冲管理？刺激大脑中与情绪控制有关的区域。该SBIR第一阶段项目将有助于产生一种新的rTMS系统，该系统将通过刺激更深层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。新设备将允许广泛分布的rTMS为基础的治疗专业临床医生，并在未来，家庭护理设置。这将避免对受抑郁症影响的人依赖药物，并将减少抑郁症对社会的影响。SBIR第一阶段项目建议开发和展示一种新的可穿戴rTMS刺激器设备的功效。虽然rTMS对抑郁症患者的成功率为75%，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，导致高脱落率。这主要是由于市售rTMS设备的电磁脉冲定位不良。新系统将结合联合收割机一种刺激大脑的新技术？大脑最深处的抑郁区域以前所未有的精确度和一个新的保护罩，旨在抵御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有效性，并将其集成到可穿戴头盔中。该项目还将证明新设备优于当前的黄金标准rTMS解决方案。该公司预计，这项研究将导致产生一种新的设备，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NSF的法定使命，并通过使用基金会的智力价值和更广泛的影响审查标准进行评估，被认为值得支持。