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）：目的是设计，建立和临床评估Parkinstim”，这是一种基于家庭的，无创的大脑极化系统，用于治疗帕金森氏病（PD）。当前的药物干预和深层脑刺激的治疗标准和深度脑刺激（DBS）的治疗（DBS）较少，较少的直接刺激（较少的刺激），较昂贵的刺激（TDC）是TDC的替代性，TDC是TDC这可能有助于治疗PD症状，减少药物使用，并减少睡眠障碍。经颅电刺激（TES）和快速的经颅磁刺激（RTMS）可能会很痛苦并引起副作用，包括癫痫发作和精神病性症状，TDC无痛，很少造成副作用，并且是家庭使用的理想选择，因为它可以以廉价和紧凑的包装提供。 Parkinstim的主要创新包括1）适合家庭用途的易于使用的可穿戴TDCS硬件，2）一种在睡眠期间提供TDC的技术； 3）一种治疗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，患有PD的患者可以在整夜睡觉和使用之前很容易脱掉。由于前一天药物后的早晨经常感到最糟糕，因此夜间刺激可能会帮助患者醒来感觉更好。此外，设计用于通宵使用的设备将使系统方便且易于使用，因此患者不必担心在公共活动或日常活动中使用该设备。开发将集中于治疗PD的运动症状；但是，所提出的系统可能证明对其他PD症状或相关的睡眠障碍有益。在此第I阶段，我们的目标是1）通过安全有效地使用现有的刺激和电极硬件来证明技术可行性，以便在睡眠期间向PD患者提供TDC，并通过证明TDC降低PD症状严重程度并降低症状波动，从而向PD患者提供TDC。十个PD受试者将参加一项平衡的跨界临床研究，在此期间，在该受试者睡眠实验室和标准的多摄影数据中，将TDC应用于M1。第一阶段的成功标准包括在睡眠期间安全有效地为PD患者施用TDC，而不会引起醒来并证明TDC的急性治疗作用。虽然I期旨在评估TDC的急性益处，但第二阶段将在几周内研究家庭使用的多个晚上TDC的慢性益处。我们假设由I阶段和II期开发产生的最终系统将在睡眠期间提供安全有效的TDC，减轻PD症状严重性，最大程度地减少运动的波动，减少所需的药物并提高睡眠质量。 公共卫生相关性：帕金森氏病影响了近150万美国人，年度治疗费用接近250亿美元。尽管当前药物干预和深脑刺激（DBS）的治疗标准显示出有效治疗PD症状，但睡眠期间经颅直流电流刺激（TDC）是一种较低的且较少的侵入性潜在替代/辅助治疗，几乎没有帮助治疗PD症状，减少药物治疗并减少睡眠障碍。成功的开发将导致安全，易于使用的家庭TDCS治疗系统PD患者在夜间可以使用，以使白天感觉更好。