Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs (TRC-AB-1)

Mahesh Pattabiraman

Status: Invitation-only

Conditions: Pain Modulation; Chronic Pain Management; Chronic Neuropathic Pain; Spinal Cord Stimulation (SCS); Failed Back Surgery Syndrome

Treatments: Device: Spinal Cord Stimulation - Neurosphere; Device: Spinal Cord Stimulation - In Clinic

Study type: Observational

Funder types: Industry

Identifiers

NCT06647576

IIS-24-ABT-001

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.)

Trial design

20 participants in 2 patient groups

Test

Description:

Patients receiving SCS therapy through Neutrosphere virtual clinic platform (remote pain management group).

Treatment:

Device: Spinal Cord Stimulation - Neurosphere

Control Group

Description:

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

Treatment:

Device: Spinal Cord Stimulation - In Clinic