ParkinStim: Transcranial Direct Current Stimulation for Parkinson's Disease

ParkinStim：经颅直流电刺激治疗帕金森病

• 批准号: 8314478
• 负责人: Dustin A. Heldman
• 金额: $ 29万
• 依托单位: GREAT LAKES NEUROTECHNOLOGIES
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-03-15 至 2015-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314478
• 关键词: Acute; Adverse effects; Affect; American; Bradykinesia; Brain; Cerebral cortex; Chronic; Clinical; Clinical Research; Custom; Data; Deep Brain Stimulation; Development; Device Designs; Devices; Dyskinetic syndrome; Effectiveness; Electric Stimulation; Electrodes; Ensure; Environment; Esthesia; FDA approved; Feeling; Head; Home environment; Intervention; Laboratories; Lead; Levodopa; Modality; Motor; Motor Cortex; Operative Surgical Procedures; Outcome Measure; Output; Pain; Painless; Parkinson Disease; Patients; Pharmaceutical Preparations; Pharmacologic Substance; Phase; Polysomnography; Population Study; Porifera; Saline; Scalp structure; Seizures; Severities; Sleep; Sleep Disorders; Sleep Stages; Sleep disturbances; Specific qualifier value; Symptoms; System; Techniques; Therapeutic; Therapeutic Effect; Transcranial magnetic stimulation; Treatment Cost; Tremor; base; design; disease diagnosis; drug standard; effective therapy; electric impedance; improved; innovation; sensor; success

DESCRIPTION (provided by applicant): The objective is to design, build, and clinically assess ParkinStim", a home-based, noninvasive brain polarization system used during sleep to treat Parkinson's disease (PD). While current therapeutic standards of drug intervention and deep brain stimulation (DBS) show effective treatment of PD symptoms, transcranial direct current stimulation (tDCS) is a less expensive and less invasive potential alternative/adjunct treatment with few side effects that may help treat PD symptoms, decrease medication usage, and reduce sleep disturbances. Recent studies have demonstrated that noninvasive anodal tDCS applied to the scalp over primary motor cortex (M1) can improve PD symptoms. tDCS provides polarization to the cerebral cortex via painless weak currents transmitted through noninvasive scalp electrodes. Unlike other noninvasive stimulation modalities such as transcranial electrical stimulation (TES) and rapid transcranial magnetic stimulation (rTMS) that can be painful and cause side effects including seizures and psychotic symptoms, tDCS is painless, poses few side effects, and is ideal for home use since it can be provided in an inexpensive and compact package. The primary innovations of ParkinStim include 1) easy-to-don wearable tDCS hardware suitable for home use, 2) a technique for providing tDCS during sleep, and 3) a therapeutic tDCS system to treat PD symptoms and related sleep disturbances. The proposed system will provide a wearable device that patients with PD can easily don before going to sleep and use through the night. Since patients often feel worst in the morning after medication from the previous day has worn off, stimulation during the night may help patients wake up feeling better. Additionally, designing the device for overnight use will make the system convenient and accessible so patients need not worry about using the device in public or during their daily activities. Development will focus on treating the motor symptoms of PD; however, the proposed system may prove beneficial for other PD symptoms or related sleep disturbances. For this Phase I, we aim to demonstrate 1) technical feasibility by safely and effectively using existing stimulation and electrode hardware to provide tDCS to PD patients during sleep and 2) clinical feasibility by demonstrating that tDCS reduces PD symptom severities and decreases symptom fluctuations. Ten PD subjects will participate in a counterbalanced crossover clinical study during which tDCS is applied to M1 while the subject sleeps in a sleep laboratory and standard polysomnography data is collected. Phase I success criteria include safely and effectively administering tDCS to PD patients during sleep without causing waking and demonstrating an acute therapeutic effect of tDCS. While Phase I is designed to evaluate the acute benefits of tDCS, Phase II will investigate the chronic benefits of multiple nights of tDCS used in the home over several weeks. We hypothesize that the final system resulting from Phase I and II development will provide safe and effective tDCS during sleep, decrease PD symptom severities, minimize motor fluctuations, reduce required medication, and improve sleep quality. PUBLIC HEALTH RELEVANCE: Parkinson's disease affects nearly 1.5 million Americans with annual treatment costs approaching $25 billion. While current therapeutic standards of drug intervention and deep brain stimulation (DBS) show effective treatment of PD symptoms, transcranial direct current stimulation (tDCS) during sleep is a less expensive and less invasive potential alternative/adjunct treatment with few side effects that may help treat PD symptoms, decrease medication usage, and reduce sleep disturbances. Successful development will result in a safe, easy-to-use home-based tDCS therapy system PD patients can use during the night to feel better during the day.

描述（由申请人提供）：目标是设计、构建和临床评估“ParkinStim”，这是一种家用非侵入性脑极化系统，用于在睡眠期间治疗帕金森病 (PD)。虽然目前药物干预和深部脑刺激 (DBS) 的治疗标准显示出对 PD 症状的有效治疗，但经颅直流电刺激 (tDCS) 是一种更便宜、侵入性更小的潜在替代/辅助治疗，副作用很少 这可能有助于治疗帕金森病症状、减少药物使用并减少睡眠障碍。最近的研究表明，将无创阳极 tDCS 应用于初级运动皮层 (M1) 上的头皮可以改善 PD 症状。 tDCS 通过无创头皮电极传输无痛微弱电流，为大脑皮层提供极化。与其他无创刺激方式不同，例如 经颅电刺激 (TES) 和快速经颅磁刺激 (rTMS) 可能会带来疼痛，并引起包括癫痫和精神病症状在内的副作用，而经颅直流电刺激 (tDCS) 无痛，副作用很少，并且可以以廉价且紧凑的包装提供，因此非常适合家庭使用。 ParkinStim 的主要创新包括 1) 适合家庭使用的易于佩戴的可穿戴 tDCS 硬件，2) 一种提供 睡眠期间的 tDCS，以及 3) 用于治疗 PD 症状和相关睡眠障碍的治疗性 tDCS 系统。拟议的系统将提供一种可穿戴设备，帕金森病患者可以在入睡前轻松佩戴并整夜使用。由于前一天的药物药效过后，患者通常会在早上感觉最糟糕，因此夜间的刺激可能会帮助患者醒来时感觉更好。此外，将设备设计为夜间使用将使系统变得方便且易于使用，因此患者无需 担心在公共场合或日常活动中使用该设备。开发将集中于治疗帕金森病的运动症状；然而，所提出的系统可能对其他帕金森病症状或相关睡眠障碍有益。对于第一阶段，我们的目标是证明 1) 通过安全有效地使用现有的刺激和电极硬件在睡眠期间向 PD 患者提供 tDCS 的技术可行性，以及 2) 通过证明 tDCS 降低 PD 症状严重程度的临床可行性 并减少症状波动。 10 名 PD 受试者将参加一项平衡交叉临床研究，其中 tDCS 应用于 M1，同时受试者在睡眠实验室中睡眠并收集标准多导睡眠图数据。 I 期成功标准包括在睡眠期间安全有效地对 PD 患者进行 tDCS 治疗而不会导致醒来，并展示 tDCS 的急性治疗效果。虽然第一阶段旨在评估 经颅直流电刺激 (tDCS) 的急性益处，第二阶段将研究数周内在家中使用多个晚上的经颅直流电刺激 (tDCS) 的长期益处。我们假设 I 期和 II 期开发的最终系统将在睡眠期间提供安全有效的 tDCS，降低 PD 症状严重程度，最大限度地减少运动波动，减少所需药物并提高睡眠质量。 公共卫生相关性：帕金森病影响着近 150 万美国人，每年的治疗费用接近 250 亿美元。虽然目前药物干预和深部脑刺激 (DBS) 的治疗标准显示出对 PD 症状的有效治疗，但睡眠期间经颅直流电刺激 (tDCS) 是一种成本较低、侵入性较小的潜在替代/辅助治疗，副作用很少，可能有助于治疗 PD 症状、减少药物使用和减少睡眠障碍。成功的开发将带来一种安全、易于使用的家用 tDCS 治疗系统，PD 患者可以在夜间使用，以便在白天感觉更好。