20
Participants
Start Date
October 8, 2024
Primary Completion Date
August 31, 2026
Study Completion Date
October 31, 2026
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.
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.
Grand Island Pain Relief Center, Grand Island
Mahesh Pattabiraman
INDUSTRY