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OpenTrials
Completed

NCT Number: NCT06647576

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

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.

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Key information

Conditions

Chronic Neuropathic Pain Back Pain Chronic Pain Chronic Pain Management Failed Back Surgery Syndrome Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pain Modulation Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postoperative Complications Signs and Symptoms Spinal Cord Stimulation (SCS)

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Grand Island Pain Relief Center

Grand Island, Nebraska, 68803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

Other names: neuromodulation, In Person SCS

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.

Other names: Remote Pain Management

Primary outcomes

  1. Pain Relief - NRS

    Time frame: Baseline, 1 month, 3 months, and 6 months post-intervention

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

  2. Quality of Life and Functional Disability Improvements - ODI

    Time frame: 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

  3. Healthcare Cost Reduction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mahesh Pattabiraman

Industry

Registry information

Official study title

Abbott Neurosphere™ Pilot Study: Remote Monitoring and Virtual Clinic Features in Improving Quality of Life and Potential Cost-Saving

Acronym: TRC-AB-1

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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