Recruiting

Closed-Loop SCS

Sponsor:

Stanford University

Code:

NCT06377969

Conditions

Chronic Pelvic Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation

Study Details

Brief 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

Study ID

NCT06377969

Start date

Jun 1, 2025

Status verified date

Mar, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Treatment

Patient will go through trial of spinal cord stimulator. If trial results in >50% reduction in pain, they will receive implantable spinal cord stimulator

Interventions

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

Primary outcome measure

  • Change in Pain Intensity [ Time Frame: Baseline, 3-month, 6-month and 12-month ]

Central Contacts and Locations

Central contacts

Vafi Salmasi, MD

6507250246vsalmasi@stanford.edu

Locations

Stanford

Recruiting

Redwood City, California, United States, 94063

Contacts

Vafi Salmasi, MD

650-725-0246vsalmasi@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2026-03-11.