A Randomized, Comparison Study of the Safety and Efficacy of Spinal Cord Stimulation Versus Standard of Care Medical Management in the Treatment of Diabetic Polyneuropathy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
To obtain preliminary estimates of the safety and efficacy of the ANS Eon™ Implantable Pulse Generator with ANS leads in the treatment of subjects with diabetic polyneuropathy.
详细描述
There is a medication arm and a stimulation arm. Patients will randomized to one or the other. If patients are randomized to the medication arm, after 6 months they have the option of going into the stimulation arm. There is a 3 week trial which includes a crossover period from "no stimulation" to subthreshold stimulation. The 3rd week patients will receive "optimal" stimulation. If they qualify, they will be implanted with the permanent device.
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
- Double (Participant, Investigator)
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
- •The subject is 18 years of age or older
- •The subject has signed and received a copy of an informed consent form after the nature of the study has been fully explained.
- •The subject has a clinical diagnosis of diabetes mellitus
- •The subject has an A1C less than or equal to 10% within the last 3 months.
- •The subject has been on a stable diabetic therapy for at least 3 months without hospitalizations for control of diabetes.
- •The subject has a documented clinical diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy using the LANSS (Leeds assessment of neuropathic symptoms and signs) pain scale score of 12 or greater and the TNS (total neuropathy score) score of 20 or greater.
- •The subject has bilateral, moderate to severe pain from diabetic polyneuropathy for the previous 3 months.
- •The subject has a VAS of > 4 at Baseline, on a stable analgesic regimen consisting of any one or combination of the following agents: anticonvulsants, antidepressants, and opioids for 1 month.
- •The subject has been shown to be refractory to conservative therapy by failing a minimum of 3 conservative treatments at least one of which is a medication specifically for diabetic polyneuropathy of adequate dose and duration
- •Female subject has a negative pregnancy test.
排除标准
- •Subject is unwilling or unable, in the opinion of the investigator, to comply with study instructions.
- •Subject has other severe pain that could confound the assessment of pain due to diabetic polyneuropathy.
- •Subject has a neuropathy that the investigator considers is not due to diabetes (e.g., significant vasculitis, collagen vascular disorder, medications known to cause neuropathies, history of familial neuropathy, drug or alcohol abuse, hepatitis, HIV, infection or pernicious anemia)
- •Subject has had any amputation.
- •Subject has a diagnosis within the past 1 year of major psychiatric disturbance. Exclusionary psychiatric diagnoses include the following Axis I disorders (DSM-IVR criteria): major depression, bipolar disorder, schizophrenia or other psychotic disorder or somatoform disorders. The Axis II disorder of borderline personality is also excluded.
- •Subject has co-existent, major systemic disease(s) that would interfere with interpretation of study results (e.g. malignancy, poorly controlled diabetes, ischemic cardiac disease, profound autonomic dysfunction or any other disease in the opinion of the investigator.)
- •Subject who has an abnormal PT, PTT, bleeding time or platelet count that might interfere with therapy.
- •Subject is currently participating in or has, within the past 30 days, participated in a study of another investigational drug or device.
- •Subject has a history of substance abuse within the past 2 years.
- •Subject has a demand-type pacemaker or implanted cardiac defibrillator.
- •Subject who require diathermy or MRIs.
- •Subject with any metallic implants that might interfere with this therapy in the opinion of the investigator;
- •Subject who has an implanted medication pump or implanted neurostimulation device.
- •Subject who currently has an active infection.
- •Subject who currently has foot ulcers.
研究组 & 干预措施
Subthreshold programming
During one of the first 2 weeks of the trial the subject will be randomized to a subthreshold stimulation arm. They will be blinded and receiving therapy, but will it will be delivered at a level (subthreshold) that they will not feel the stimulation.
干预措施: ANS Eon™ Implantable Pulse Generator (Permanent Implant) (Device)
Placebo or Stimulation off arm
During one of the first two weeks of the study, the patient will be randomized to a no stimulation arm. They will be blinded and will not be receiving therapy.
干预措施: Placebo (Device)
Placebo or Stimulation off arm
During one of the first two weeks of the study, the patient will be randomized to a no stimulation arm. They will be blinded and will not be receiving therapy.
干预措施: ANS Eon™ Implantable Pulse Generator (Permanent Implant) (Device)
Optimal stimulation programming
During the third week of the trial period, all subjects will receive optimal stimulation.
干预措施: ANS Eon™ Implantable Pulse Generator (Permanent Implant) (Device)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 24 months
The VAS is a 100mm line that indicates severity of pain progression
次要结局
- Intra-epidermal skin biopsy(24 months)
- Nerve conduction studies and Electromyogram (EMG)(24 months)
- Inflammatory mediators (IL-6, IL-1β, and CRP)(24 months)
- Vascular Doppler(24 months)
- Short Form 36 (SF-36) Quality of Life Questionnaire(24 months)
- Device related and serious adverse events(24 months +/- 6 months depending on study arm randomization)
- Neuropathy Impairment in the Lower Limbs (NIS-LL)(24 months)