NCT07507422招募中不适用
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable SCS Therapy (PERSIST) Addendum - Inceptiv™ Spinal Cord Stimulation (SCS) Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Medtronic
- 入组人数
- 970
- 试验地点
- 6
- 主要终点
- Percentage of implanted patients who have a ≥ 50% improvement in pain score as assessed by numeric pain rating scale (NPRS) from baseline for the predominant pain being treated at 6 months following device activation
研究概览
简要总结
The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR). The purpose of PERSIST is to generate long-term evidence for the Inceptiv™ Spinal Cord Stimulation therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient must be SCS therapy naïve
- •A clinical decision was made for the patient to receive an Inceptiv™ SCS system (pending satisfactory results from a Medtronic SCS trial) limited to on-label leads based on the specific geography for an on-label indication prior to enrollment in the study.
- •Patient is on stable opioid dosage for 3 months prior to enrollment, if applicable
- •Pain intensity of ≥ 6 as measured using the NPRS (0-10) in the predominant area(s) of pain that SCS is intended to treat
- •Patient must have an on-label indication specific to geography.
- •NOTE: Patients may be enrolled if they have upper limb radicular limb pain, related or unrelated to spine surgery
- •NOTE: In the US, patients experiencing chronic back pain without a history of spine surgery and not eligible for spine surgery are on-label candidates for SCS if the pain is associated with degenerative disc disease, herniated disc, or radicular pain syndrome. Radicular pain syndrome (with or without prior spine surgery) is an approved indication for SCS implant.
- •Diagnosis of chronic back and/or limb pain for an on-label indication lasting at least six months.
排除标准
- •Has any existing or is planning to have a new active implantable neuromodulation device or system during the 5 year follow up period (e.g., peripheral nerve stimulation, sacral neuromodulation, intrathecal drug delivery system, a second SCS system)
- •Has a complex pain pattern that involves both upper and lower limbs or back and upper limb
- •Has a planned major medical procedure within 6 months before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator
- •Has a planned interventional procedure within 6 weeks (+/- 2 weeks) before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator
- •Major untreated or unstable psychiatric comorbidity, such as suicidal ideations, personality disorders, schizophrenia etc., that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study, as determined by the Investigator
- •Subjects with PCS total score >30 are not eligible unless ALL of the following are met:
- •Absence of uncontrolled major psychiatric disorder or active suicidality based on clinical evaluation.
- •Investigator documentation of adequate understanding of therapy, realistic expectations, and anticipated compliance with protocol follow-up
- •Major non-indicated, untreated or refractory progressive disease (e.g., neurodegenerative disease {not including Diabetic Peripheral Neuropathy}, heart failure, cancer, osteoarthritis, fibromyalgia, chronic fatigue syndrome), or injury (e.g., fall resulting in hip fracture) that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study as determined by the Investigator
- •Has inpatient or outpatient admissions for drug or alcohol dependency within past 12 months or current/ongoing substance abuse
- •Has a current prescription of ≥90 morphine milligram equivalents (MME) per day
- •Has predominant mechanical back pain arising from facet or sacroiliac joint pain as the main cause of chronic low-back pain if low-back pain is the predominant pain condition, as determined by the Investigator
- •Has mechanical spine instability (eg. Spondylolisthesis grade 2) as determined by the Investigator
- •Has an active systemic or local infection that would delay trial or implant
- •Is pregnant or planning on becoming pregnant
- •Has a life expectancy of less than 1 year
- •Involved in an injury claim, under current litigation, beneficiary of an injury claim, receiving worker's compensation, or planning any future litigation
- •Has a condition that the Investigator determines would significantly increase perioperative risk (e.g., unstable or severe cardiac disease, liver disease, uncontrolled diabetes, kidney disease)
- •Patients enrolled into the study with Diabetic Peripheral Neuropathy, Complex Regional Pain Syndrome and Upper Limb pain are required to meet further inclusion/exclusion criteria in order to contribute to the analysis for that particular condition. These criteria are designed to ensure that the patient's condition aligns with the standard diagnostic criteria set by applicable clinical guidelines.
- •Painful Diabetic Peripheral Neuropathy (DPN) Inclusion Criteria
- •Clinical diagnosis of diabetes mellitus according to the American Diabetes Association guidelines (ADA).
- •Predominant pain condition being treated by SCS is lower-limb pain due to DPN
- •Hemoglobin A1c (HbA1c) must be <8% within 6 months of enrollment for inclusion or have completed a preoperative risk assessment if >8%
- •Presence of either numbness or at least one sensory disturbance (e.g., increased or decreased sensitivity, burning, pricking/stabbing, aching, "pins and needle" sensation) in the foot/feet.
- •Painful DPN Exclusion Criteria
- •Lower-limb pain not associated with DPN or that cannot be distinguished from DPN (e.g., mononeuropathies, proximal neuropathies, nonneuropathic pain, peripheral vascular disease)
- •History of lower-limb amputation or planned lower-limb amputations due to diabetes
- •Large (≥3cm) and/or gangrenous ulcers or active infection of the lower limbs
- •Complex Regional Pain Syndrome (CRPS) Inclusion Criteria
- •Meets diagnostic criteria for CRPS (International Association for the Study of Pain "Budapest Criteria")
- •Disease that is clinically restricted to one hand or foot and affects the entire hand, foot or lower extremity
- •CRPS is the predominant pain condition that SCS is intended to treat
- •CRPS Exclusion Criteria
- •Presence of Reynaud's disease
- •Current or previous neurologic abnormalities unrelated to CRPS
- •Another condition affecting the function of the diseased or contralateral extremity
- •Dystonia as a predominant component of their presentation
- •Upper Limb Pain (ULP) - non CRPS Inclusion Criteria
- •Be diagnosed with radicular pain syndrome, or be diagnosed with radicular pain secondary to failed back surgery or herniated disk
- •ULP - non CRPS Exclusion Criteria
- •Has significant cervical stenosis, as determined by the Investigator
- •Failed treatments of carpal tunnel syndrome and/or cubital tunnel syndrome
- •Has mechanical neck pain (e.g., facet spondylosis), as determined by the Investigator
- •Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine
- •Has brachial plexus injury as predominant cause of pain
研究组 & 干预措施
PERSIST Cohort
干预措施: Commercially available Inceptiv™ neurostimulation systems (Device)
结局指标
主要结局
Percentage of implanted patients who have a ≥ 50% improvement in pain score as assessed by numeric pain rating scale (NPRS) from baseline for the predominant pain being treated at 6 months following device activation
时间窗: Baseline and 6 months after device activation
This outcome measures the percentage of implanted patients who demonstrate improvement in pain for the predominant pain condition being treated at 6 months following device activation, compared to baseline. Pain is assessed using the NPRS (with 0=no pain and 10=highest level of pain).
Percentage of implanted patients who are a composite responder at 6 months following device activation
时间窗: Baseline and 6 months after device activation
A composite responder is defined as an implanted patient who demonstrates an improvement from baseline in at least one of the following measures at the specified follow-up time: pain, quality of life, or pain-related disability. Pain is assessed using the Numeric Pain Rating Scale (NPRS 0=no pain and 10=worst possible pain), with improvement defined as a reduction in pain score from baseline. Quality of life is assessed using the EQ-5D-5L index value, with improvement defined as positive change from baseline. Pain-related disability is assessed using the Pain Disability Index (PDI), with improvement defined as negative change from baseline.
次要结局
- Percentage of implanted patients who are a composite responder(Baseline and 3 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months after device activation)
研究者
研究点 (6)
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