NCT06897280进行中（未招募）4 期
A Single-Center, Prospective Clinical Trial of MED HF10™ Spinal Cord Stimulation for the Treatment of Chronic Pain
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- Nevro Corp
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Preference for Pulse Dose Setting
研究概览
简要总结
This is a single-center, prospective, non-randomized exploratory study in subjects with chronic, intractable back pain and/or leg pain per the center's routine practice. The primary endpoint is the distribution of responders by 'lowest preferred pulse dose (PD)' setting, where a subject is a responder to the lowest PD setting they preferred prior to entering the Observational period. The study is performed in patients who already have Nevro SCS devices implanted.
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
- •Have been diagnosed with chronic, intractable pain of the back pain with or without leg pain
- •Have been implanted with the Nevro Senza™ or Omnia SCS system with dual leads, approximately over vertebral T8-T11, for at least 3 months, and are using the system with single area, continuous 10 kHz stimulation programs at least 18 hours daily, as determined by subject reporting and confirmation via device diagnostics, for at least 21 days prior to enrolling in this study
- •If taking them, be on stable chronic pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in the study and be willing to stay on those medications with no dose adjustments until study completion or study withdrawal, whichever comes first.
- •Be 18 years of age or older at the time of enrollment
- •Be willing and able to comply with study-related requirements, procedures, and visits
- •Be capable of subjective evaluation, able to read and understand IRB approved written questionnaires, and are able to read, understand and sign the IRB approved written informed consent, all of which will be in American English
- •Be compliant in using the patient programmer and recharger as determined by the Investigator.
- •As determined by the Investigator, be compliant in adjusting programs using the device remote control.
- •Have >= 30% pain relief in primary pain area intended to be treated by SCS.
排除标准
- •Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as
- •Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome.
- •Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, or acute herniating disc, as determined by the investigator.
- •Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention.
- •Having undergone an interventional procedure and/or surgery to treat back or leg pain other than Senza HF10 therapy in the last 30 days
- •Have a condition currently requiring or likely to require diathermy
- •Have a condition currently requiring or likely to require surgery during the study period.
- •Have metastatic malignant disease or active local malignant disease
- •Have a life expectancy of less than 1 year
- •Have an active systemic or local infection
- •Be pregnant or planning to become pregnant during the course of the study (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
- •Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
- •Be concomitantly participating or planned to be participating in another clinical study overlapping in time with the present clinical study
- •Have an existing drug pump and/or another active implantable device (switched On or Off) such as a pacemaker or other non-Senza™ SCS devices
- •Have an unresolved condition of device-related pain (e.g. IPG pocket
- •Have a condition currently requiring or likely to require surgery during the study period.
研究组 & 干预措施
Single arm
Experimental
Pulse Dosing
干预措施: SCS Device Program Setting (Device)
结局指标
主要结局
Preference for Pulse Dose Setting
时间窗: 3 months
Starting from a standardized low pulse dose (PD) setting, subjects will try progressively lower PD settings depending upon their response to each setting, to arrive at the lowest PD setting they prefer. Up to 5 PD settings will be tried by each subject.
次要结局
- Numerical Rating Scale of Back, Leg, and Overall Pain Intensity(3 months)
- Patient Satisfaction(3 months)
- Patient Global Impression of Change(3 months)
- Oswestry Disability Index(3 months)
- Patient Catastrophizing Scale(3 months)
- PROMIS-SF Sleep Disturbance Scale(3 months)
- Daily device recharge duration(3 months)
研究者
研究点 (2)
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