Abbott Neurosphere™ Pilot Study: Remote Monitoring and Virtual Clinic Features in Improving Quality of Life and Potential Cost-Saving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Pain Relief - NRS
研究概览
简要总结
This study evaluates the effectiveness of Abbott's Proclaim™ and Eterna™ Spinal Cord Stimulator (SCS) systems, along with the Neurosphere™ virtual clinic platform, in managing chronic pain. The goal is to assess how remote monitoring and virtual care can improve pain relief and reduce healthcare costs compared to traditional in-person care. Adults with chronic pain will either receive treatment through in-person visits or remotely using Neurosphere™. The study will measure pain relief, quality of life, and healthcare expenses over six months, aiming to improve access to pain management, especially for patients in rural areas.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years and older experiencing chronic neuropathic pain that is refractory to medical treatment and eligible for SCS based on FDA-approved indications.
- •Individuals who can legally provide informed consent.
排除标准
- •Patients unable or unwilling to adhere to the requirements of remote monitoring, follow-up schedules, or other aspects of the study protocol.
- •Patients with uncontrolled psychiatric conditions, including severe depression or anxiety, which could interfere with their ability to participate fully in the study or accurately report outcomes.
- •Women who are currently pregnant or breastfeeding, as the safety and efficacy of SCS in these populations are not established.
- •Patients who have previously experienced significant adverse events or complications from SCS implantation or stimulation that would make further use unsafe or ineffective.
- •Patients with other active implantable devices (e.g., pacemakers or defibrillators) that could interfere with the functionality of the SCS system.
- •Patients with a documented history of substance abuse within
- •Patients with significant comorbid conditions (severe cardiovascular disease, unmanaged diabetes, uncontrolled infection, etc.)
研究组 & 干预措施
Test
Patients receiving SCS therapy through Neutrosphere virtual clinic platform (remote pain management group).
干预措施: Spinal Cord Stimulation - Neurosphere (Device)
Control Group
Participants in this group will receive traditional in-person care for their SCS therapy. Group regular clinic visits for therapy adjustments, monitoring, and pain management
干预措施: Spinal Cord Stimulation - In Clinic (Device)
结局指标
主要结局
Pain Relief - NRS
时间窗: Baseline, 1 month, 3 months, and 6 months post-intervention
Pain relief in numerical pain rating scale (NRS). Numerical points.
Quality of Life and Functional Disability Improvements - ODI
时间窗: Baseline, 1 month, 3 months, and 6 months post-intervention
Change in quality of life and functional disability in participants quantified through numerical response to Oswestry Disability Index (ODI) compared to baseline
Healthcare Cost Reduction
时间窗: From baseline to 6 months post-intervention
This outcome measures the reduction in healthcare costs associated with the use of the Neurosphere™ remote monitoring platform compared to traditional in-person care. Costs will be assessed through an analysis of healthcare resource utilization using time-driven activity-based costing TDABC methodology.
次要结局
未报告次要终点
研究者
Mahesh Pattabiraman
Chief Executive
TriCity Research Center