Closed-loop spinal cord stimulation for chronic pelvic pain — effectiveness and safety
Prospective Evaluation of Effectiveness and Safety of Closed-Loop Spinal Cord Stimulation in Treating Patients With Chronic Pelvic Pain
This study will test whether closed-loop spinal cord stimulation can safely reduce chronic pelvic pain in adults whose pain has not improved with standard treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Redwood City, California) |
| Trial ID | NCT06377969 on ClinicalTrials.gov |
What this trial studies
This prospective interventional study enrolls adults with chronic pelvic pain lasting more than six months that has not responded to conservative medical management. Participants receive an ECAP-controlled closed-loop spinal cord stimulator that adjusts stimulation energy in real time based on evoked compound action potential feedback. Investigators will follow participants to measure safety, pain reduction, and functional outcomes over the follow-up period. Procedures and follow-up are conducted at Stanford University in Redwood City, California.
Who should consider this trial
Good fit: Adults aged 18 or older with chronic pelvic pain longer than six months that has not responded to conservative medical treatments and without treatable secondary causes are ideal candidates.
Not a fit: Patients with uncontrolled medical or major untreated psychiatric conditions, anatomical barriers to SCS placement, or ongoing legal or disability claims are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could offer better-controlled and more durable pain relief for adults with refractory chronic pelvic pain.
How similar studies have performed: Conventional open-loop spinal cord stimulation has shown benefit for some pelvic pain patients, but ECAP-controlled closed-loop systems are relatively new and have limited published evidence specific to pelvic pain.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: * 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
Where this trial is running
Redwood City, California
- Stanford — Redwood City, California, United States (Recruiting)
Study contacts
- Study coordinator: Vafi Salmasi, MD
- Email: vsalmasi@stanford.edu
- Phone: 6507250246
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.