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

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Stanford University

Status

Begins enrollment in 2 months

Conditions

Chronic Pelvic Pain Syndrome

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Treatment
Other group
Description:
Patient will go through trial of spinal cord stimulator. If trial results in \>50% reduction in pain, they will receive implantable spinal cord stimulator
Treatment:
Device: ECAP (Evoked Compound Action Potential)-controlled Closed-Loop Spinal Cord Stimulation

Trial contacts and locations

0

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Central trial contact

Vafi Salmasi, MD

Data sourced from clinicaltrials.gov

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