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RecruitingNot ApplicableNCT06377969

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

Sponsor

Stanford University

Enrollment

10 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Pelvic Pain Syndrome

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • The investigators will include all adult patients (18 or older) with pelvic pain more than 6 months that has not responded to conservative medical management

Exclusion Criteria5

  • Major untreated medical comorbidities (uncontrolled diabetes mellitus, severe obesity, uncontrolled cardiopulmonary disease, etc.)
  • Secondary causes of pelvic pain that can be treated with appropriate medical or surgical interventions
  • Major untreated psychological comorbidities
  • Anatomical challeneges to place spinal cord stimulator
  • Ongoing legal or disability claims
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Interventions

DEVICEECAP (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

Locations(1)

Stanford

Redwood City, California, United States

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NCT06377969

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