Clinical trial NCT06647576: Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs
Official title: Abbott Neurosphere™ Pilot Study: Remote Monitoring and Virtual Clinic Features in Improving Quality of Life and Potential Cost-Saving
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
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
Lead sponsor: TriCity Research Center
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.)

Primary outcomes:
measure: Pain Relief - NRS
timeFrame: Baseline, 1 month, 3 months, and 6 months post-intervention
measure: Quality of Life and Functional Disability Improvements - ODI
timeFrame: Baseline, 1 month, 3 months, and 6 months post-intervention
measure: Healthcare Cost Reduction
timeFrame: From baseline to 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Island
country: United States
facility: Grand Island Pain Relief Center
state: Nebraska
Study officials:
References: