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

NCT ID: NCT06377969

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-06-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

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

Intervention Type: 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

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

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vafi Salmasi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Vafi Salmasi, MD

Role: CONTACT

vsalmasi@stanford.edu

6507250246

Other Identifiers

75269

Identifier Type: -

Identifier Source: org_study_id