A Digital Therapeutic for Pain Relief through AI-Guided Visual Stimulation

项目摘要 Danvillage ™成立于2020年，致力于开发神经和精神疾病的数字疗法， 通过眼睛与大脑互动。本SBIR的目标是设计和测试一种安全、有效和非 视觉刺激形式的成瘾性疼痛缓解数字治疗。该平台将使用人工智能 (AI)和实时生物反馈来“读取”（破译）大脑信号和“写入”（神经调节）大脑， 快速变化的视觉刺激，由优化的图案、颜色和频率组成。这是第一次尝试 使用人工智能引导的视觉刺激来治疗疼痛。2017年，1.91亿张处方中有1100万张 滥用阿片类止痛药，35%的阿片类药物相关死亡（近17，000例） 与这些处方有关在寻找安全、有效的替代品时， 通过药理学、临床和数字化行为平台开发了干预措施， 没有一个被证明是完全成功的。丹泽尔假设疼痛的复杂性和多变性需要 一种模拟大脑本身处理和整合疼痛感知数据的治疗方法。 通过其新颖的神经调节平台，使用人工智能来参数化潜在有用的视觉 信息，Danvillage将开发一种安全，低成本的数字治疗，患者可以在智能手机上查看 或片剂立即缓解疼痛。通过将刺激与不同类型疼痛的反应相关联， 丹尼迪克特还希望建立一个适用范围更广的疼痛感知地图。在第一阶段， 将开发一个平台，可以合成新的刺激组合，并根据 来自一系列生物传感器的反馈;然后， 在健康受试者中进行测试。在第二阶段，丹佛斯将把原型开发成商业上可用的 产品和测试疼痛缓解数字治疗的有效性和普遍性，在随机对照 审判商业机会估计为59亿美元。

PROJECT SUMMARY Dandelion™ was founded in 2020 to develop digital therapeutics for neurologic and psychiatric disorders by interacting with the brain via the eyes. The goal of this SBIR is to design and test a safe, effective, and non- addictive pain-relief digital therapeutic in the form of visual stimuli. The platform will use artificial intelligence (AI) and real-time biofeedback to “read” (decipher) brain signals and “write” to (neuromodulate) the brain with rapid-changing visual stimuli composed of optimized patterns, colors, and frequencies. This is the first attempt to use AI-guided visual stimuli as a treatment for pain. In 2017, 11 million of the 191 million prescriptions written for opioid pain medications were misused, and 35% of opioid-related deaths (nearly 17,000 cases) were connected to these prescriptions. In the search for safe, effective alternatives, a range of opioid-sparing interventions have been developed through pharmacologic, clinical, and digitized behavioral platforms but none has proved fully successful. Dandelion hypothesizes that the complexity and variability of pain demands a therapeutic approach that mimics the way the brain itself processes and integrates data for pain perception. Through its novel neuromodulatory platform, using artificial intelligence to parameterize potentially useful visual information, Dandelion will develop a safe, low-cost digital therapeutic that patients can view on a smartphone or tablet for immediate pain relief. By correlating stimulus with response across different types of pain, Dandelion also hopes to build a pain-perception map of wider applicability. In Phase I a prototype AI-guided platform will be developed that can synthesize novel stimulation combinations and optimize them based on feedback from an array of biosensors; their efficacy in reducing the perception of induced pain will then be tested in healthy subjects. In Phase II, Dandelion will develop the prototype into a commercially available product and test the pain-relief digital therapeutic for efficacy and generalizability in randomized controlled trials. The commercial opportunity is estimated to be $5.9 billion.