A Clinical Evaluation of Direct Dorsal Column Stimulation for the Management of Chronic, Medically Refractory Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Feasibility as measured by interview and questionnaire
研究概览
简要总结
The study will examine the feasibility of Direct Dorsal Column Stimulation using existing Stimulation Leads (Ad-Tech). Secondary endpoints will include pain relief, somatosensory evoked potentials (SSEPs), stimulator settings required, improvement in quality of life and use of pain medications.
详细描述
Please note: This phase I feasibility study did not meet the expected enrollment goal of 75. The study only enrolled 6 subjects and therefore no participant completed phase II of the trial described below.
The primary objective of this study is to test the hypothesis that direct dorsal column stimulation is safe in the treatment of medically refractory, chronic neuropathic pain. The study will examine the feasibility of Direct Dorsal Column Stimulation using existing Stimulation Leads (Ad-Tech). Secondary endpoints will include pain relief, somatosensory evoked potentials (SSEPs), stimulator settings required, improvement in quality of life and use of pain medications.
Design & procedures This study is designed as a prospective, controlled exploratory study for an acute duration SCS trial system implantation. We will quantify perception of pain and stimulation-evoked paresthesias in response to both epidural and subdural direct dorsal column SCS. Additionally, we will measure the effects of both SCS modalities on somatosensory evoked potentials (SSEPs), patient quality of life, and satisfaction with treatment.
The normal clinical course of SCS for chronic pain includes a trial period of 3-30 days during which test stimulation is delivered via temporarily implanted epidural electrodes with an external percutaneous stimulation device. These electrodes are removed at the end of the trial period and, following a successful trial, a permanent set of electrodes and stimulation device are implanted at a later date. Subjects for this study will be recruited from patients planning to undergo percutaneous trial or paddle lead SCS implantation under the care of Dr. Nandan Lad at Duke University Medical Center.
Those subjects who a) have post-laminectomy pain syndrome and are considered good candidates for SCS trials, b) previously had successful SCS but have become refractory c) did not have adequate coverage during a prior SCS trial, or d) have been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotics administration will be considered for participation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects enrolled in this study must meet the following inclusion criteria:
- •Primary pain type-neuropathic with concordant neurologic findings
- •Subject age is 18 years or older;
- •Subjects who meet one of the following four criteria:
- •diagnosed with medically refractory chronic neuropathic pain, post laminectomy pain syndrome or failed back surgery syndrome.
- •previously had successful SCS, but gradually became refractory
- •did not have adequate coverage during a prior SCS trial,
- •been deemed refractory to all other treatments and would otherwise receive an intrathecal catheter/pump for chronic narcotics administration
- •Disease duration of at least 6 months with no lasting success with standard therapy and medications.
- •Mean pain intensity of at least 5 cm (or greater), measured on a visual analog scale from 0 (no pain) to 10 cm (severe pain) on a 10 cm line;
- •Psychological screening has been completed and the patient has been cleared by a psychologist or psychiatrist as a suitable SCS candidate;
- •Subject is willing to cooperate with the study requirements including compliance with the treatment regimen, the follow-up visit schedule and completion of the study diary;
- •Female candidates of childbearing potential must have a negative serum pregnancy test.
- •MRI or CT myelogram of the lumbar and thoracic spine (within 12 months prior to screening) rules out a pathology that might compromise SCS electrode placement or pathology, in addition to neural compression that might contribute to the subject's pain
- •Provide informed consent to participate in the study; -
排除标准
- •A subject will be excluded from participation in this study if they meet any one of the following criteria:
- •Pain attributed to: vascular disorder; musculoskeletal disorder; substance abuse or withdrawal; infection; disorder of homeostasis;
- •Subjects currently participating in another clinical trial;
- •Subject has an existing intrathecal drug pump
- •Active local or systemic infection
- •Unresolved issues of secondary gain (e.g., litigation)
- •Expected inability to adequately report treatment outcome
- •A concurrent clinically significant or disabling chronic pain problem or condition that is likely to confound evaluation of study endpoints (e.g., chronic migraine, significant arthritis of the hip associated with groin pain as primary complaint)
- •Radiographic evidence of frank instability (grossly mobile spondylolisthesis or abnormal subluxation) requiring fusion, calcific arachnoiditis, or severe thoracic or lumbar stenosis.
- •Subjects who have a condition that requires diathermy or repeat MRI's;
- •New medication for pain control has been initiated within 8 weeks prior to the initial baseline;
- •Female candidates of child bearing potential who are pregnant (confirmed by positive serum pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child;
- •Subject has a blood clotting disturbance or requires chronic anticoagulant drug therapy
- •The Investigator deems that the subject is not suitable for the study even if they meet all other inclusion/exclusion criteria.
结局指标
主要结局
Feasibility as measured by interview and questionnaire
时间窗: 3-5 days after Successful SCS trial lead placement defined as at least 50% reduction in pain or adequate paresthesia coverage in the painful areas.
The subject will be asked to complete various questionnaires about their pain characteristics, consisting of pain rating scales and subjective recordings and ratings of stimulation intensity, duration, timing and location of pain.
次要结局
未报告次要终点