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

NCT06377969 | Recruiting

• 1 other identifier: 75269
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Numerical Rating Scale (0-10; higher score is worse)

  Baseline, 3-month, 6-month and 12-month

Secondary Outcomes (6)

• Change in Disability

  Baseline, 3-month, 6-month and 12-month

• Patient Global Impression Change

  Baseline, 3-month, 6-month and 12-month

• Change in Quality of Life

  Baseline, 3-month, 6-month and 12-month

• Change in Pain Catastrophizing Scale

  Baseline, 3-month, 6-month and 12-month

• Change in sleep quality

  Baseline, 3-month, 6-month and 12-month

Study Arms (1)

Treatment

OTHER

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

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

Interventions

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

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford

Redwood City, California, 94063, United States

RECRUITING

Central Study Contacts

Vafi Salmasi, MD

CONTACT

6507250246; vsalmasi@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pilot prospective single arm interventional study

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)