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）：过去十年来，脑刺激装置的应用快速增加，以治疗各种运动障碍，例如帕金森氏病（PD）和其他神经病理学。当前的无创脑刺激技术受到根本局限性的损失，并且尚未达到侵入性方法的功效水平，例如深脑刺激（DBS）。电体刺激（ESSTIM）是一种改进的非侵入性方式，可提供更局灶性和更深效果的潜力。与其他形式的非侵入性刺激（例如，经颅DC刺激（TDC））相比，使用该技术的初步研究证实了焦点和穿透性的改善，这些刺激已转化为与其他技术相比，这些刺激已转化为更大的刺激效果和持续时间。该应用的重点是评估ESTIM对PD患者的治疗影响。首先，在第一阶段，我们将在为期两周的时间内将24例PD患者（12个假患者，12个主动刺激）持续固定固定剂量的10天刺激，每天20分钟。我们将评估患者中的电生理学，认知和神经系统安全标记，包括64通道EEG，加利福尼亚计算机化评估套件，言语流利性测试，N-BACK工作记忆测试，PD不良效果问卷和神经学检查。此外，我们将评估PD患者的统一帕金森氏病评级量表（UPDRS），Bradykinesia测试和步行能力/步态，并在2周期间进行了评估，并在上次刺激会议之后至少六个星期进行了评估。在第二阶段，我们将在两周的时间内给出48例PD患者（12例假患者（12例假运动刺激，12 TDC和12 tus）），持续固定剂量的刺激为10天，每天20分钟20分钟。我们将用电动机，安全性，机械和生活质量（QOL）测试来评估这些患者，并比较测试干预措施的功效。与PD处理同时，将通过基于MRI的计算模型开发在大脑中产生的电磁和声磁场的现场模型，并与基于个体化患者数据的治疗过程中记录的在治疗过程中记录的有效性指标相关。总体而言，我们假设提出的实验，计算研究和技术开发将使我们能够与PD患者其他非侵入性技术相比，测试ESSTIM的有效性。拟议工作的结果将是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。通过这种技术和刺激方法未来的发展可以为创新和改善的神经疗法提供一个平台。

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