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Chronic Neuropathic Pain
+4

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

Sponsored by Mahesh Pattabiraman

About this trial

Last updated 8 months ago

Study ID

IIS-24-ABT-001

Status

Enrolling by invitation

Type

Observational

Placebo

No

Accepting

18-75 Years
19+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 9 months ago

What is this trial 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.

What are the participation requirements?

Yes

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.

No

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.)

Locations

Location

Status