Noninvasive Neural Stimulation Technology

无创神经刺激技术

• 批准号: 8918035
• 负责人: Timothy Andrew Wagner
• 金额: $ 88.51万
• 依托单位: HIGHLAND INSTRUMENTS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-01 至 2017-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8918035
• 关键词: Activities of Daily Living; Adverse effects; Adverse event; Aftercare; Authorization documentation; Back; Bradykinesia; Brain; California; Characteristics; Clinical; Clinical Research; Cognitive; Computer Simulation; Confidential Information; Coupling; Data; Deep Brain Stimulation; Development; Devices; Disease; Dopaminergic Agents; Dose; Double-Blind Method; Effectiveness; Electroencephalography; Electromagnetics; Electrophysiology (science); Equipment; Future; Gait; Implant; Intervention; Magnetic Resonance Imaging; Measures; Metabolic; Methods; Modality; Modeling; Motor; Motor Cortex; Motor Evoked Potentials; Movement Disorders; Multicenter Studies; Neurologic; Operative Surgical Procedures; Outcome; Output; Parkinson Disease; Patients; Penetration; Phase; Physiologic pulse; Quality of life; Questionnaires; Randomized; Research; Rights; Risk; Safety; Short-Term Memory; Site; Small Business Innovation Research Grant; Source; Structure; Surface; Symptoms; Tardive Dyskinesia; Techniques; Technology; Testing; Therapeutic; Therapeutic Effect; Time; Tissues; Transcranial magnetic stimulation; Transducers; Translating; Ultrasonics; Ultrasonography; United States National Institutes of Health; Visit; Walking; Work; base; behavioral study; clinical effect; commercialization; comparative efficacy; computer studies; computerized; efficacy testing; follow-up; functional outcomes; human subject; improved; innovation; instrument; motor disorder; neural stimulation; neuropathology; phase 1 study; phase 2 study; randomized placebo controlled trial; relating to nervous system; research study; technology development

DESCRIPTION (provided by applicant): The past decade has seen a rapid increase in the application of brain stimulation devices to treat a variety of movement disorders, such as Parkinson's disease (PD), and other neuropathologies. Present noninvasive brain stimulation technologies suffer from fundamental limitations and have yet to reach the level of efficacy of invasive methods, such as deep brain stimulation (DBS). Electrosonic Stimulation (ESStim) is an improved noninvasive modality, which offers the potential of more focal and deeper effects. Preliminary studies with this technique have confirmed improved focality and penetration compared to other forms of noninvasive stimulation (e.g., transcranial DC stimulation (tDCS)), which have translated into a greater magnitude and duration of stimulatory effect compared to the other technologies. This application is focused on evaluating the therapeutic impact of ESStim in PD patients. First in Phase I, we will follow 24 PD patients (12 SHAM, 12 active ESStim stimulation) after giving a constant fixed dose of ESStim for 10 days of stimulation, 20 mins/day, over a two-week period. We will assess a battery of electrophysiology, cognitive, and neurological safety markers in the patients including 64 channel EEG, California Computerized Assessment Package, verbal fluency test, n-back working memory test, PD Adverse Effects Questionnaire, and neurological exams. Additionally, we will evaluate the Unified Parkinson's Disease Rating Scale (UPDRS), bradykinesia test, and walking abilities/gait in the PD patients, evaluated over the 2-week period and for at least six weeks following the last stimulation session. Next in Phase II, we will follow 48 PD patients (12 SHAM, 12 active ESStim stimulation, 12 tDCS, and 12 TUS) after giving a constant fixed dose of stimulation for 10 days, 20 mins/day, over a two-week period. We will evaluate these patients with a battery of Motor, Safety, Mechanistic, and Quality of Life (QOL) tests, comparing the efficacy of the tested interventions. In parallel with the PD treatments, field models of the electromagnetic and sonic fields generated in the brain will be developed with MRI based computational models of each patient and correlated with the efficacy measures recorded during and after the treatment sessions to develop dosing models based on the individualized patient data. Overall, we hypothesize that the proposed experiments, computational studies, and technology development will allow us to test the effectiveness of ESStim compared to other noninvasive technologies in PD patients. The results of the proposed work will serve as the basis for a future large-scale multicenter study to further validate the technique and optimize equipment for use in PD therapy. Future developments with this technology and stimulation method could provide a platform for innovative and improved neurological treatments.

描述（由申请人提供）：在过去十年中，脑刺激装置用于治疗各种运动障碍（如帕金森病（PD）和其他神经病变）的应用迅速增加。目前的非侵入性脑刺激技术受到根本性的限制，并且尚未达到侵入性方法（诸如深部脑刺激（DBS））的功效水平。超声电刺激（ESStim）是一种改进的非侵入性方式，它提供了更多的焦点和更深的影响的潜力。与其他形式的无创刺激（例如，经颅DC刺激（tDCS）），与其他技术相比，其已经转化为更大幅度和持续时间的刺激效果。该应用程序的重点是评价ESStim在PD患者中的治疗影响。首先在I期，我们将在两周内给予恒定固定剂量的ESStim刺激10天（20分钟/天）后随访24例PD患者（12例假刺激，12例活性ESStim刺激）。我们将评估患者的一系列电生理学、认知和神经安全性标志物，包括64通道EEG、加州计算机化评估包、语言流畅性测试、n-back工作记忆测试、PD不良反应问卷和神经系统检查。此外，我们将在2周内和末次刺激后至少6周内评价PD患者的统一帕金森病评定量表（Unified Parkinson's Disease Rating Scale，简称CIMRS）、运动迟缓试验和步行能力/步态。接下来在II期，我们将在两周内给予恒定固定剂量的刺激10天（20分钟/天）后随访48例PD患者（12例假手术，12例主动ESStim刺激，12例tDCS和12例TUS）。我们将对这些患者进行一系列运动、安全、机械和生活质量（QOL）测试，比较测试干预措施的疗效。与PD治疗并行，将使用每例患者基于MRI的计算模型开发大脑中产生的电磁场和声场的场模型，并与治疗期间和治疗后记录的疗效指标相关联，以基于个体化患者数据开发给药模型。总的来说，我们假设，拟议的实验，计算研究和技术开发将使我们能够测试的有效性ESStim相比，其他非侵入性技术在PD患者。拟议工作的结果将作为未来大规模多中心研究的基础，以进一步验证该技术并优化用于PD治疗的设备。这项技术和刺激方法的未来发展可以为创新和改进的神经治疗提供平台。

项目成果

Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel.

• DOI: 10.3109/10601333.2015.980944
• 发表时间: 2015-03-01
• 期刊: Clinical research and regulatory affairs
• 作者: Fregni F;Nitsche MA;Loo CK;Brunoni AR;Marangolo P;Leite J;Carvalho S;Bolognini N;Caumo W;Paik NJ;Simis M;Ueda K;Ekhitari H;Luu P;Tucker DM;Tyler WJ;Brunelin J;Datta A;Juan CH;Venkatasubramanian G;Boggio PS;Bikson M
• 通讯作者: Bikson M