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

Part of paid clinical trials in Redwood City, California.

Sponsor
Stanford University
Study ID
NCT06377969
Status
Recruiting
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Conditions

  • Chronic Pelvic Pain Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Mar 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
StanfordRedwood CityCalifornia94063
Vafi Salmasi, MD
[email protected]
650-725-0246

Find similar trials in Redwood City, CA

By research site
Stanford· Redwood City, CA

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