Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bioness Inc
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Implant Success
研究概览
简要总结
This study is being done to see how well a new investigational medical device, the StimRouter (STR) System, will work to treat the chronic pain in people who have failed previous treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been treated for CTS pain before including surgical carpal tunnel release, but without good results, and they are still having pain. The study will look at both the good and bad effects of the StimRouter System for treating this kind of pain and as a general peripheral nerve stimulation device for treating chronic pain. The study will also help to understand other possible uses for the StimRouter System.
详细描述
This is a prospective, single-center, open label study designed to evaluate the clinical use of the StimRouter (STR) as a peripheral nerve stimulation device for the treatment of chronic pain. The clinical study is proposed to serve as an evaluation of the preliminary StimRouter design, proposed implantation techniques, electrical stimulation parameters, and outcome measures for the StimRouter. The current study will utilize the median nerve (in the context of carpal tunnel syndrome (CTS), status-post a single failed carpal tunnel release (CTR) surgery)as a model to represent the device's more general intended use as a peripheral nerve stimulator to treat chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Chronic peripheral pain persisting for greater than or equal to 3 months diagnosed previously as a mononeuropathy of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS)
- •Average chronic pain level greater than or equal to 5/10 [on 0-10 numeric rating scale (NRS) (BPI#14)], where such pain is attributed to injury, irritation, or entrapment of the median nerve at the level of the carpal tunnel (i.e., diagnosed CTS)
- •Failure of a single prior carpal tunnel release surgery to provide relief, where such failed surgery was performed greater than or equal to study entry
- •Able to tolerate stimulation (TENS)
- •Temporary pain relief is achieved by local anesthetic block of the target median nerve suspected to be the source of chronic pain symptoms
- •Ability to give informed consent and understand study requirements
- •Ability to quantify pain using a 0-10 numeric rating scale [A screening tool will be used to ensure that subjects can rate 3 common pain scenarios (mosquito bite, stubbed toe and broken bone) on a 0-10 NRS relative to each other, with mosquito bite < stubbed toe < broken bone]
- •Willing and able to understand and comply with all study-related procedures during the course of the study
- •Motivated to maintain an accurate diary for the study duration
排除标准
- •Metal implants in the forearm
- •Active infection
- •Active or existing skin disorder or irritation which, at the physician's discretion, contraindications use of skin gel electrodes
- •Allodynia
- •Regular use of antiplatelet medications [e.g., aspirin, ticlopidine (Ticlid), clopidogrel (Plavix), tirofiban (Aggrastat), and eptifibatide (Integrilin)]
- •Anticoagulated (taking warfarin or heparin, including fractionated heparin) or has a bleeding disorder
- •Cardiac pacemaker
- •Implanted neurostimulator (e.g., spinal cord, deep brain, vagus nerve stimulator) or implanted pump or infusion device
- •History of cardiac arrhythmia with homodynamic instability
- •Untreated drug habituation or dependence
- •Psychologically or medically unstable
- •Uncontrolled seizures (averaging > 2 seizures per month)
- •Pregnant or plan on becoming pregnant or breastfeeding during the study period
- •Currently require, or likely to require, diathermy and/or MRI during the study duration
- •History of adverse reactions to local anesthetic (e.g., lidocaine)
结局指标
主要结局
Implant Success
时间窗: at device implantation procedure
Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of the procedure. Fluoroscopic imaging was used to document positioning of the StimRouter Lead and, by applying stimulation from a commercially available Dakmed External Pulse Generator (EPG) to the StimRouter Lead, desired paresthesia response was confirmed.
次要结局
- Percent of Participants Reporting Pain Change From Baseline to Day 5(Day 5)
- Patent Satisfaction(Day 5 after final stimulation)
- Mean Change in Pain Achieved by Participants Who Reported Pain Change From Baseline to Day 5(Day 5 after final stimulation)