SynchronyGamma: A Music-Based Intervention for Alzheimer's and Mild Cognitive Impairment

SynchronyGamma：针对阿尔茨海默病和轻度认知障碍的基于音乐的干预措施

• 批准号: 10484478
• 负责人: Edward W Large
• 金额: $ 44.97万
• 依托单位: OSCILLOSCAPE, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2023-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10484478
• 关键词: Adoption; Adult; Affect; Age-associated memory impairment; Aging; Algorithms; Alzheimer' s Disease; Alzheimer' s disease model; Alzheimer' s disease patient; Alzheimer' s disease therapy; American; Amyloid beta-Protein; Auditory; Behavior; Behavior Therapy; Behavioral Symptoms; Brain; Caregivers; Caring; Clinical; Cognition; Collaborations; Communities; Computer Models; Conduct Clinical Trials; Data; Devices; Disease; Early Intervention; Elderly; Electroencephalography; Executive Dysfunction; Feasibility Studies; Frequencies; Functional disorder; Funding; Goals; Human; Impaired cognition; Independent Living; Individual; Institutional Review Boards; Intervention; Interview; Lead; Learning; Legal patent; Light; Lighting; Longitudinal Studies; Measures; Memory; Memory Loss; Mental Depression; Modeling; Music; Neurodegenerative Disorders; Neurologist; Neurons; Neuropsychology; Neurosciences; Outcome; Outcome Measure; Pain; Participant; Patient Self-Report; Patients; Periodicity; Pharmacology; Phase; Photic Stimulation; Population; Process; Protocols documentation; Public Health; Research; Retirement; Rewards; Self-Help Devices; Senile Plaques; Sensory; Short-Term Memory; Small Business Innovation Research Grant; Structure; System; Technology; Testing; Time; United States National Institutes of Health; Universities; Visual; Work; base; cognitive ability; cognitive neuroscience; cost; digital health; experience; feasibility testing; improved; innovation; instrument; medical schools; mild cognitive impairment; mouse model; neural network; novel; novel therapeutics; patient population; preservation; prototype; relating to nervous system; response; secondary outcome; success; targeted biomarker; tool; usability

Project Summary/Abstract In this proposal, Oscilloscape, LLC seeks NIH-SBIR funding to conduct usability and feasibility studies on an innovative music-based digital health device that delivers non-invasive music and Gamma (30-80 Hz) brain stimulation to help aging adults with Alzheimer’s Disease (AD) and Mild Cognitive Impairment (MCI). The digital health device, herein referred to as “SynchronyGamma,” is based on patented neural network technology that models the dynamics of rhythmic brain activity. We previously used this neural network technology to develop a scalable, low-cost LED-light controller, called Synchrony™, that creates colorful lighting effects that synchronize to the beat of music. Synchrony™ is currently marketed for music lighting, but its core algorithm has clinical potential, because it aims to stimulate healthy brain rhythms via the process of neural entrainment. In clinical populations who have disruptions in brain rhythms, e.g., patients with AD & MCI, we hypothesize that this technology can effectively restore normal brain activity important for learning, memory, and cognition. Key outcomes of this project are IRB-approved studies that 1) assess the usability of SynchronyGamma in independent living facilities, and 2) assess the feasibility of SynchronyGamma as a brain stimulation tool by studying the effects of SynchronyGamma on brain activity and cognitive abilities in a longitudinal intervention in older adults with MCI or AD. SynchronyGamma has potential to help age-related cognitive impairments by creating a music-based, digital health device that delivers Gamma stimulation via music and lights. Neurodegenerative disorders are a rapidly growing public-health concern, with AD alone projected to affect 13.8 million Americans in 2050. AD patients undergo gradual cognitive decline, with MCI being an early stage of the disorder. During this progression, patients experience multiple pain-points, including memory loss, executive function deficits, and depression. Early intervention in the MCI stage may reduce or even reverse cognitive decline. While pharmacological interventions for AD have primarily targeted biomarkers such as beta- amyloid (Aβ) plaques, these strategies have shown limited success in improving clinical outcomes. Thus, there is an urgent clinical need to develop novel therapies for AD and MCI. Recent findings that relate Gamma neural entrainment to Aβ offer an exciting avenue towards non-invasive sensory interventions. Our objective is to validate SynchronyGamma as an effective music-based therapy for restoring depleted brain activity, thus preserving and improving memory and cognition in patients with AD and MCI.

项目总结/摘要 在本提案中，Oscilloscape，LLC寻求NIH-SBIR资助，以开展可用性和可行性研究。 研究一种创新的基于音乐的数字健康设备，提供非侵入性的音乐， 伽马（30-80 Hz）脑刺激，以帮助老年人阿尔茨海默病（AD）和 轻度认知障碍（MCI）。数字健康设备，在本文中被称为 “SynchronyGamma”基于专利神经网络技术， 有节奏的大脑活动我们以前使用这种神经网络技术来开发一种 可扩展、低成本的LED灯控制器，称为Synchrony™，可创造丰富多彩的照明效果 与音乐的节拍同步。Synchrony™目前用于音乐照明，但 它的核心算法具有临床潜力，因为它旨在通过刺激健康的大脑节律， 神经夹带的过程。在临床人群中， 例如，在一个实施例中，对于AD和MCI患者，我们假设该技术可以有效地恢复正常， 大脑活动对学习记忆和认知很重要该项目的主要成果是 IRB批准的研究：1）评估SynchronyGamma在独立生活中的可用性 设施，以及2）通过以下方式评估SynchronyGamma作为脑刺激工具的可行性： 研究SynchronyGamma对大脑活动和认知能力的影响， 对MCI或AD老年人的干预。 SynchronyGamma有可能通过创造一种 基于音乐的数字健康设备，通过音乐和灯光提供伽马刺激。 神经退行性疾病是一个快速增长的公共卫生问题，仅AD 预计到2050年将影响1380万美国人。AD患者经历逐渐的认知障碍 MCI是疾病的早期阶段。在这个过程中，患者 经历多个痛点，包括记忆丧失，执行功能缺陷， 萧条MCI阶段的早期干预可能会减少甚至逆转认知能力下降。 虽然AD的药理学干预主要针对生物标志物，如β- 淀粉样蛋白（Aβ）斑块，这些策略在改善临床 结果。因此，临床上迫切需要开发用于AD和MCI的新疗法。 最近的研究结果表明，伽马神经夹带Aβ提供了一个令人兴奋的途径， 非侵入性的感官干预。我们的目标是验证SynchronyGamma作为 有效的基于音乐的治疗，用于恢复耗尽的大脑活动，从而保持和 改善AD和MCI患者的记忆和认知。