Abbott Neurosphere™ Pilot Study: Remote Monitoring and Virtual Clinic Features in Improving Quality of Life and Potential Cost-Saving
| Registry | NCT06647576, acronym TRC-AB-1 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 32 (Actual) |
| Sponsor | Mahesh Pattabiraman (Industry) |
| Conditions | Chronic Neuropathic Pain, Chronic Pain Management, Spinal Cord Stimulation (SCS), Pain Modulation, Failed Back Surgery Syndrome |
| Interventions | Spinal Cord Stimulation - In Clinic, Spinal Cord Stimulation - Neurosphere (Device) |
| Dates | start 2024-10-08, primary completion 2026-04-30, completion 2026-05-07, first posted 2024-10-18, last updated 2026-05-08 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Test | Device: Spinal Cord Stimulation - Neurosphere | Patients receiving SCS therapy through Neutrosphere virtual clinic platform (remote pain management group). | |
| Control Group | Device: Spinal Cord Stimulation - In Clinic | 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 |
Sex: All, ages: 19 Years to any
Inclusion Criteria: * 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. Exclusion Criteria: * 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.)
| Facility | City | Country | Status |
|---|---|---|---|
| Grand Island Pain Relief Center | Grand Island, Nebraska | United States |