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

NCT06647576 | Enrolling By Invitation FDA Device

• 1 other identifier: IIS-24-ABT-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

chronic pain; spinal cord stimulation; neuropathic pain; Remote Pain Management; BurstDR Technology; Chronic Pain in Rural Populations

Outcome Measures

Primary Outcomes (3)

• Pain Relief - NRS

  Pain relief in numerical pain rating scale (NRS). Numerical points.

  Baseline, 1 month, 3 months, and 6 months post-intervention

• Quality of Life and Functional Disability Improvements - ODI

  Change in quality of life and functional disability in participants quantified through numerical response to Oswestry Disability Index (ODI) compared to baseline

  Baseline, 1 month, 3 months, and 6 months post-intervention

• Healthcare Cost Reduction

  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.

  From baseline to 6 months post-intervention

Study Arms (2)

Test

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

Device: Spinal Cord Stimulation - Neurosphere

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

Device: Spinal Cord Stimulation - In Clinic

Interventions

Spinal Cord Stimulation - In Clinic 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.

Also known as: neuromodulation, In Person SCS

Control Group

Spinal Cord Stimulation - Neurosphere 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.

Also known as: Remote Pain Management

Test

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include adult participants aged 19 years and older who are experiencing chronic neuropathic pain that is refractory to medical treatment and are eligible for SCS therapy based on FDA-approved indications. Participants will be recruited from a rural population, with effort made for including individuals from diverse socioeconomic backgrounds. Study will enroll patients who can legally provide consent and are willing to adhere to the study protocol, including remote monitoring or in-person follow-up visits.

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Mahesh Pattabiraman: lead

Study Sites (1)

Grand Island Pain Relief Center

Grand Island, Nebraska, 68803, United States

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Chronic Pain; Neuralgia

Interventions

Spinal Cord Stimulation; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Executive

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 18, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)