NCT06377969

Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Spinal cord stimulation (SCS) is an effective treatment for patients with chronic pelvic pain. The investigators will evaluate how safe and effective closed-loop spinal cord stimulation is in treating these patients; closed-loop spinal cord stimulation is a more novel method in delivering spinal cord stimulation that controls energy output of the device based on real-time feedback on how the device is stimulating the spinal cord.

Conditions

• Chronic Pelvic Pain Syndrome

Interventions

Type	Name	Description
DEVICE	ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation	The patients will receive externalized epidural leads connected to external pulse generator for 5-14 days during trial phase. If the trial results in \>50% reduction in pain, they will undergo a minor surgery to receive implantable spinal cord stimulator

Timeline

• Start date: 2025-06-01
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2024-04-22
• Last updated: 2026-03-11

Locations

1 site across 1 country: United States