Wireless Tibial Nerve Stimulation Therapy for Overactive Bladder
无线胫神经刺激疗法治疗膀胱过度活动症
基本信息
- 批准号:8643323
- 负责人:
- 金额:$ 21.33万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2014
- 资助国家:美国
- 起止时间:2014-06-01 至 2016-05-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAdultAffectAmericanAnimal ModelAnimalsBehavior TherapyBladderBladder ControlChargeChronicClinicalClinical TrialsDataDevicesElectric StimulationEnsureEuropeFelis catusFrequenciesFundingGoalsHome environmentHumanImplantIncontinenceLifeMaintenanceMarketingMethodsModalityModelingNerveNerve FibersNeurostimulation procedures of spinal cord tissueOffice VisitsOperative Surgical ProceduresOveractive BladderPain in lower limbPatientsPerformancePharmaceutical PreparationsPhasePhysiologic pulsePopulationPosterior Tibial NervesQuality of lifeRattusRecruitment ActivityRelaxationReportingSleepSmall Business Innovation Research GrantSocial isolationStructure of tibial nerveSymptomsSystemTechnologyTestingTherapeuticTreatment ProtocolsTreatment outcomeUnited StatesUnited States National Institutes of HealthVisitWireless TechnologyWitbasechronic back painchronic paincompliance behaviorconventional therapydesigneffective therapyfootimplantationminimally invasiveneuroregulationpatient populationpressurepublic health relevanceresponsesafety testingvoltage
项目摘要
DESCRIPTION (provided by applicant): The goal of this SBIR Phase 1 proposal is to determine the feasibility of wireless neuromodulation for controlling bladder function. Overactive bladder (OAB) affects about 16.5% of the adult population in both the United States and Europe. Percutaneous electrical stimulation of the posterior tibial nerve (PTN) recently emerged as an effective, yet minimally invasive alternative to failed conventional behavioral modifications drug treatments, and more invasive surgical approaches. This therapy is commercially available as the Urgent PC(R) system (Uroplasty, Inc, Minnetonka, MN). However, the repeated office visits needed to achieve and sustain the clinical benefits of Urgent PC proves to be a great impediment to the use of this product. Thus, while stimulation of the PTN remains a top target for reaching the untreated sufferers of OAB, a clinically acceptable and practical method of implementing this treatment is lacking. As a result millions of patients remain untreated. The long-term goal of this project is to restore quality of life to those suffering with OAB by providig patients with a means of treating themselves in their own home as needed. This approach will overcome the primary weakness of the Urgent PC therapy. Rossellini Scientific is partnering with Stimwave Technologies to apply their wireless implant technology to a form factor and therapeutic treatment protocol appropriate for electrical PTN stimulation. In this Phase 1 proposal, our first specific aim is to test the feasibility of using our wirelessly powered nerve stimulator to reflexively inhibit the urinary bladder - and hence increase bladder capacity - in an
acute animal model. We plan to expand our preliminary data that showed electrical nerve stimulation using a voltage-controlled capacitive discharge (VCCD) waveform requires less charge per pulse than traditional constant-current (CC) stimulation. We will determine whether VCCD or CC stimulation is most appropriate for electrically modulating bladder function. We will also determine target stimulation parameters for wireless neuromodulation of bladder function to be used in planned clinical trials. The second specific aim is to test the chronic performance of the implant in animals to ensure stability of device function. To conclude that our device and approach are feasible, we must observe at least a 30% decrease in bladder pressure (induce relaxation), and that bladder volume is increased by e 50% under the conditions of this study. We must also find that our device effectively stimulates following 4, 8, and 12 weeks of implantation. If our device is effective in these models, then we will apply to the NIH for Phase 2
funding to carry out a clinical trial to test safety, efficacy, and patient compliance.
描述(由申请人提供):SBIR第1阶段提案的目标是确定无线神经调节用于控制膀胱功能的可行性。膀胱过度活动症(OAB)影响美国和欧洲约16.5%的成年人口。胫后神经(PTN)的经皮电刺激最近成为一种有效的,但微创的替代失败的传统行为矫正药物治疗,更具侵入性的手术方法。该疗法作为Urgent PC(R)系统(Uroplasty,Inc,明内通卡,MN)市售。然而,实现和维持紧急PC的临床受益所需的反复办公室访问被证明是使用该产品的巨大障碍。因此,虽然PTN的刺激仍然是用于达到未经治疗的OAB患者的最高目标,但是缺乏实施这种治疗的临床上可接受的和实用的方法。因此,数百万患者仍然得不到治疗。该项目的长期目标是通过为OAB患者提供一种在自己家中治疗自己的方法来恢复OAB患者的生活质量。这种方法将克服紧急PC治疗的主要弱点。Rossellini Scientific正在与Stimwave Technologies合作,将其无线植入技术应用于适用于电PTN刺激的形状因子和治疗方案。在这个第一阶段的提案中,我们的第一个具体目标是测试使用我们的无线供电神经刺激器反射性抑制膀胱的可行性,从而增加膀胱容量。
急性动物模型我们计划扩展我们的初步数据,这些数据表明使用电压控制电容放电(VCCD)波形的电神经刺激比传统的恒流(CC)刺激需要更少的每脉冲电荷。我们将确定VCCD或CC刺激是否最适合电调节膀胱功能。我们还将确定用于计划临床试验的膀胱功能无线神经调节的目标刺激参数。第二个具体目标是测试植入物在动物体内的长期性能,以确保器械功能的稳定性。为了得出我们的设备和方法是可行的结论,我们必须观察到膀胱压力至少降低30%(诱导松弛),并且在本研究的条件下膀胱体积增加了50%。我们还必须发现,我们的设备在植入4周、8周和12周后有效刺激。如果我们的设备在这些模型中有效,那么我们将向NIH申请2期
资助开展临床试验,以测试安全性、有效性和患者依从性。
项目成果
期刊论文数量(3)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Posterior tibial nerve stimulation using a wirelessly powered system in anesthetized cats.
使用无线供电系统对麻醉猫进行胫后神经刺激。
- DOI:10.1109/embc.2016.7591717
- 发表时间:2016
- 期刊:
- 影响因子:0
- 作者:Moazzam,Zainab;Duke,AustinR;Yoo,PaulB
- 通讯作者:Yoo,PaulB
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Austin Robert Duke其他文献
Austin Robert Duke的其他文献
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{{ truncateString('Austin Robert Duke', 18)}}的其他基金
Wireless Vagal Nerve Stimulation System for Treating Atrial Fibrillation
用于治疗心房颤动的无线迷走神经刺激系统
- 批准号:
8918091 - 财政年份:2014
- 资助金额:
$ 21.33万 - 项目类别:
Wireless Vagal Nerve Stimulation System for Treating Atrial Fibrillation
用于治疗心房颤动的无线迷走神经刺激系统
- 批准号:
8645880 - 财政年份:2014
- 资助金额:
$ 21.33万 - 项目类别:
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