Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs
CompletedNCT06647576
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Abbott Neurosphere™ Pilot Study: Remote Monitoring and Virtual Clinic Features in Improving Quality of Life and Potential Cost-Saving
- Conditions
- Chronic Neuropathic Pain
- Chronic Pain Management
- Spinal Cord Stimulation (SCS)
- Pain Modulation
- Failed Back Surgery Syndrome
- Interventions
- Device: Spinal Cord Stimulation - In Clinic
- Device: Spinal Cord Stimulation - Neurosphere
- Sponsor
- Mahesh Pattabiraman
- Organization
- TriCity Research Center
- Start date
- 2024-10-08
- Primary completion
- 2026-04-30
- Sex
- All
- Age range
- from 19 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06647576