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

Enrolling by invitationOBSERVATIONAL
Enrollment

20

Participants

Timeline

Start Date

October 8, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

October 31, 2026

Conditions
Chronic Neuropathic PainChronic Pain ManagementSpinal Cord Stimulation (SCS)Pain ModulationFailed Back Surgery Syndrome
Interventions
DEVICE

Spinal Cord Stimulation - In Clinic

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.

DEVICE

Spinal Cord Stimulation - Neurosphere

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.

Trial Locations (1)

68803

Grand Island Pain Relief Center, Grand Island

All Listed Sponsors
lead

Mahesh Pattabiraman

INDUSTRY