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.

项目摘要 帕金森氏病痴呆症（PDD）是帕金森氏病（PD）患者的常常非运动症状。 PDD与认知能力下降有关，可以增加发病率和死亡率，并大大降低 病人的生活质量。四分之三的PD患者将出现PDD，但唯一是FDA批准的治疗方法 PDD是Rivastigmine，它提供短暂且充其量的效果，并且可能更糟糕的PD电机 症状。此外，帕金森运动障碍的金标准疗法（即左旋多巴和深 脑刺激）可能会导致PDD，但通常不建议停止治疗。解决这个可怕的 需要，Scion Neurostim，Inc开发了一种新型的家庭使用设备，无创刺激核里 脑干在整个大脑中发送投影以调节各种功能，包括认知， 记忆，幸福感和心情。在先前的双盲，随机对照试验中，设备八周 PD患者的运动症状大大改善了运动症状和非运动症状。设备处理是 耐受性且安全，仅频繁，短暂和轻度的副作用。重要的是，数据子分析 来自具有轻度认知障碍或痴呆症的参与者的参与者表明，设备治疗 根据蒙特利尔认知能力明显改善认知表现 评估。治疗依从性非常好，研究参与者仍然对他们的治疗视而不见 分配。此外，临床反应的动力学表明，治疗期可能更长 导致更大的临床改进。在这个项目中，Scion将进行单臂临床试验 在12个时期内，用Scion的设备评估非侵入性脑干刺激的安全性和可行性 PDD患者的数周。此外，它将探索Scion设备处理认知和其他电动机的潜力 和与PDD相关的非运动符号，如果有利，它将实现A的设计和动力 关键试验。