NCT02011893已完成不适用
Success Using Neuromodulation With BURST (SUNBURST™) Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 20
- 主要终点
- Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain
研究概览
简要总结
The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 22 years of age or older
- •Subject has chronic intractable pain of the trunk and/or limbs
- •Subject has a average score of 60 or higher for average daily overall pain on the Visual Analog Scale (VAS) 7 day pain diary
- •Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
- •Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
- •Subject agrees not to add or increase pain-related medication from activation through the 24 week follow-up visit
排除标准
- •Subject is currently participating in a clinical investigation that includes an active treatment arm
- •Subject has been implanted with a previous neurostimulation system or participated in a trial period for a neurostimulation system
- •Subject's overall Beck Depression Inventory II Score is >24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit
- •Subject has an infusion pump or any implantable neurostimulator device
- •Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment
- •Subject has an existing medical condition that is likely to require repetitive Magnetic Resonance Imaging (MRI) evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
- •Subject has an existing medical condition that is likely to require the use of diathermy in the future
- •Subject's pain originates from peripheral vascular disease
- •Subject is immunocompromised
- •Subject has documented history of allergic response to titanium or silicone
- •Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
- •Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test)
研究组 & 干预措施
Tonic Stimulation
Active Comparator
Tonic Stimulation using the Prodigy system
干预措施: Tonic Stimulation (Device)
Burst Stimulation
Experimental
Burst Stimulation using the Prodigy system
干预措施: Burst Stimulation (Device)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain
时间窗: Over 7 days after 3 months of treatment of burst or tonic stimulation
Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.
次要结局
- Percentage of Paresthesia Coverage(During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation)
- Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)(Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation)
- Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation(Over 7 days after 3 months of treatment of burst or tonic stimulation)
研究者
研究点 (20)
Loading locations...
相似试验
已完成
不适用
Evaluate St Jude Medical Prodigy Neuromodulation for FBSS or Chronic Pain of the Trunk and/or LimbsChronic PainNCT02143791Abbott Medical Devices126
招募中
不适用
Bilateral Nucleus Accumbens Focused Ultrasound Neuromodulation for Stimulant Use DisorderPsychostimulant Use Disorder(PUD)NCT06474026Korea University Anam Hospital15
已完成
1 期
Theta-Burst Neuromodulation for PTSDChronic Post-Traumatic Stress DisorderNCT02769312VA Office of Research and Development56
已完成
不适用
Bipolar Transcranial Alternating Current Stimulation (tACS)Bipolar DisorderNCT05480124University of Michigan18
已完成
不适用
Deep Brain Stimulation (DBS) for the Suppression of TremorTremorAction TremorTremor, LimbEssential TremorNCT02087046Abbott Medical Devices127