Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs

NCT ID: NCT06647576

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2026-10-31

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Test

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

Spinal Cord Stimulation - Neurosphere

Intervention Type: DEVICE

Test Group Intervention: Test group participants will receive remote monitoring and therapy adjustments through the Neurosphere™ virtual clinic platform. Participants in test group will have trial and end of trial phases in clinic, but further SCS therapy will be performed through Neurosphere. Clinicians will adjust the SCS device settings, including pulse width and burst frequency, remotely. This intervention allows patients to avoid in-person visits while receiving continuous, personalized care, with follow-up assessments at 1, 3, and 6 months over a 6-month period.

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

Spinal Cord Stimulation - In Clinic

Intervention Type: DEVICE

Control Group Intervention: In-Person SCS therapy. Device settings, such as pulse width and frequency, will be adjusted during regular clinic visits. Follow-up assessments for pain relief, quality of life, and therapy effectiveness will occur at 1, 3, and 6-month intervals over a 6-month period.

Interventions

Spinal Cord Stimulation - In Clinic

Control Group Intervention: In-Person SCS therapy. Device settings, such as pulse width and frequency, will be adjusted during regular clinic visits. Follow-up assessments for pain relief, quality of life, and therapy effectiveness will occur at 1, 3, and 6-month intervals over a 6-month period.

Intervention Type: DEVICE

Spinal Cord Stimulation - Neurosphere

Test Group Intervention: Test group participants will receive remote monitoring and therapy adjustments through the Neurosphere™ virtual clinic platform. Participants in test group will have trial and end of trial phases in clinic, but further SCS therapy will be performed through Neurosphere. Clinicians will adjust the SCS device settings, including pulse width and burst frequency, remotely. This intervention allows patients to avoid in-person visits while receiving continuous, personalized care, with follow-up assessments at 1, 3, and 6 months over a 6-month period.

Intervention Type: DEVICE

Other Intervention Names

neuromodulation; In Person SCS; Remote Pain Management

Eligibility Criteria

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.)

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahesh Pattabiraman

INDUSTRY

Sponsor Role: lead

Responsible Party

Mahesh Pattabiraman

Chief Executive

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Grand Island Pain Relief Center

Grand Island, Nebraska, United States

Countries

United States

Other Identifiers

IIS-24-ABT-001

Identifier Type: -

Identifier Source: org_study_id