Simple, Home-use, neurostimulAtion tReatment for Parkinson's disease dEmeNtia (SHARPEN)

简单的家用神经刺激疗法治疗帕金森病痴呆 (SHARPEN)

• 批准号: 10697178
• 负责人: Kristen Kathleen Foster
• 金额: $ 66.66万
• 依托单位: SCION NEUROSTIM, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-15 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10697178
• 关键词: Address; Adherence; Adjuvant Therapy; Adult; Adverse event; Affect; Bradykinesia; Brain; Brain Stem; Caregivers; Cell Nucleus; Clinic; Clinical; Clinical Research; Clinical Trials; Cognition; Cognitive; Data; Data Analyses; Deep Brain Stimulation; Dementia; Devices; Diagnostic; Diagnostic Procedure; Dose Limiting; Double-Blind Method; Economics; Enrollment; Equilibrium; External Ear; External auditory canal; FDA approved; Functional disorder; Home; Impaired cognition; Individual; Intention; Kinetics; Levodopa; Medical Device; Memory; Moods; Morbidity - disease rate; Motor; Neurodegenerative Disorders; Neurons; Organ; Parkinson Disease; Parkinson' s Dementia; Parkinsonian Disorders; Participant; Patient Outcomes Assessments; Patients; Personal Satisfaction; Persons; Phase; Placebos; Population; Probability; Protocols documentation; Quality of life; Randomized, Controlled Trials; Regulation; Reporting; Rest Tremor; Risk; Safety; Self Administration; Signs and Symptoms; Site; Sleep; Standardization; Stimulus; Symptoms; System; TNM; Testing; Therapeutic; Time; Vestibular nucleus structure; Visit; adherence rate; aged; arm; associated symptom; blind; clinical development; clinical diagnosis; clinical outcome measures; cognitive function; cognitive performance; cognitive testing; design; gastrointestinal; improved; lifetime risk; mild cognitive impairment; mortality; motor deficit; motor function improvement; motor impairment; motor symptom; non-demented; non-motor symptom; novel; novel therapeutics; response; retention rate; rivastigmine; safety and feasibility; side effect; solid state; success; treatment adherence; treatment comparison; treatment duration; urinary

PROJECT SUMMARY Parkinson’s disease dementia (PDD) is a frequent non-motor symptom in patients with Parkinson’s disease (PD). PDD is associated with cognitive decline that can increase morbidity and mortality and dramatically reduce patient quality of life. Three out of four PD patients will develop PDD, yet the only FDA-approved treatment for PDD is rivastigmine which provides effects that are short-lived and modest at best and may worsen PD motor symptoms. Furthermore, gold standard therapies for Parkinsonian motor impairments (i.e., levodopa and deep brain stimulation) can worsen PDD, yet stopping treatment is typically not recommended. To address this dire need, Scion NeuroStim, Inc has developed a novel, home-use device that non-invasively stimulates nuclei in the brainstem that send projections throughout the brain to regulate a variety of functions including cognition, memory, well-being, and mood. In a previous double-blind, randomized controlled trial, eight weeks of Device treatments dramatically improved both motor and non-motor symptoms in PD patients. Device treatments were well tolerated and safe with only infrequent, transient, and mild side effects. Importantly, a sub-analysis of data from participants with evidence of either mild cognitive impairment or dementia revealed that Device treatment was associated with significantly improved cognitive performance according to the Montreal Cognitive Assessment. Treatment adherence was excellent and study participants remained blind to their treatment allocation. Furthermore, the kinetics of the clinical responses indicate that longer treatment periods are likely to result in even greater clinical improvements. Thus, in this project, Scion will conduct a single-arm clinical trial to evaluate the safety and feasibility of non-invasive brainstem stimulation with Scion’s Device over a period of 12 weeks in PDD patients. Further, it will explore the potential for Scion’s Device to treat cognitive and other motor and non-motor symptoms associated with PDD, which, if favorable, will enable the design and powering of a pivotal trial.

项目概要 帕金森病痴呆（PDD）是帕金森病（PD）患者常见的非运动症状。 PDD 与认知能力下降有关，认知能力下降会增加发病率和死亡率，并显着降低 患者的生活质量。四分之三的 PD 患者会出现 PDD，但这是 FDA 批准的唯一治疗方法 PDD 是卡巴拉汀，其作用最多是短暂且适度的，并且可能会恶化 PD 运动 症状。此外，治疗帕金森运动障碍的金标准疗法（即左旋多巴和深部 脑刺激）可能会加重 PDD，但通常不建议停止治疗。为了解决这个可怕的问题 为了满足这一需要，Scion NeuroStim, Inc 开发了一种新型家用设备，可以非侵入性地刺激大脑中的细胞核。 脑干向整个大脑发送投射来调节各种功能，包括认知、 记忆力、幸福感和情绪。在之前的双盲、随机对照试验中，八周的设备 治疗显着改善了帕金森病患者的运动和非运动症状。设备治疗是 耐受性良好且安全，仅有罕见、短暂和轻微的副作用。重要的是，对数据进行子分析 有轻度认知障碍或痴呆症证据的参与者表明，设备治疗 根据蒙特利尔认知协会的数据，与显着改善的认知表现相关 评估。治疗依从性非常好，研究参与者对他们的治疗仍然视而不见 分配。此外，临床反应的动力学表明，较长的治疗时间可能会 带来更大的临床改善。因此，在这个项目中，Scion将进行单臂临床试验 在 12 年内评估使用 Scion 设备进行非侵入性脑干刺激的安全性和可行性 PDD 患者的周数。此外，它将探索 Scion 设备治疗认知和其他运动疾病的潜力 以及与 PDD 相关的非运动症状，如果有利的话，将能够设计和驱动一种 关键审判。