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.

项目总结 帕金森氏病痴呆(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，这会增加发病率和死亡率，并显著减少 患者的生活质量。四分之三的帕金森病患者会患上PDD，但FDA批准的唯一治疗方法是 PDD是一种利瓦斯汀，它的影响是短暂的，充其量是适度的，可能会使PD运动恶化 症状。此外，帕金森氏症运动障碍的黄金标准疗法(即左旋多巴和深部 脑刺激)会加重PDD，但通常不建议停止治疗。为了解决这一可怕的问题 Need，Scion NeuroSTim，Inc.开发了一种新型的家用设备，这种设备可以非侵入性地刺激大脑中的细胞核 脑干在整个大脑中发送投射，以调节包括认知在内的各种功能， 记忆、幸福和心情。在之前的双盲随机对照试验中，8周的装置 治疗显著改善帕金森病患者的运动和非运动症状。设备治疗是 耐受性好，安全性好，仅有少见的、短暂的和轻微的副作用。重要的是，对数据的子分析 从有轻度认知障碍或痴呆症证据的参与者那里发现，设备治疗 与认知能力的显著提高有关，根据蒙特利尔认知 评估。治疗依从性很好，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，较长的治疗周期可能会 从而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，以 12年来应用肖恩装置进行无创脑干刺激的安全性和可行性评价 在PDD患者中为3周。此外，它还将探索肖恩的设备治疗认知和其他运动的潜力 以及与PDD相关的非运动症状，如果有利，这将使设计和为 关键审判。