Closed-Loop Spinal Cord Stimulation for Chronic Pelvic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a special type of spinal cord stimulation (SCS) called ECAP-controlled Closed-Loop Spinal Cord Stimulation to determine its effectiveness for chronic pelvic pain. The treatment uses a closed-loop system that adjusts based on real-time feedback, aiming to enhance safety and effectiveness. Participants experiencing more than 50% pain reduction during the trial phase may receive a permanent implant. The trial seeks adults who have had pelvic pain for over six months without relief from standard medical treatments. As an unphased trial, it offers a unique opportunity to explore innovative treatment options for those seeking new solutions.
What prior data suggests that this closed-loop spinal cord stimulation is safe for treating chronic pelvic pain?
A previous study showed promising results for patients using ECAP-controlled closed-loop spinal cord stimulation (SCS) for chronic pain. Many reported significant pain reduction, with some experiencing over 80% relief. Importantly, this treatment appears well-tolerated. For instance, another study found that after 12 months, many patients had significant pain reduction.
Additionally, long-term follow-ups suggest few safety concerns. Patients continued to experience pain relief over time, indicating the treatment's safety for long-term use. Generally, side effects were uncommon in these studies, suggesting that this SCS approach is safe for people with chronic pain.12345Why are researchers excited about this trial?
Researchers are excited about ECAP-controlled Closed-Loop Spinal Cord Stimulation for chronic pelvic pain because it offers a more personalized approach to pain management. Unlike standard treatments like medications or open-loop spinal cord stimulation, this method uses real-time feedback to adjust stimulation based on the patient's responses, potentially leading to better pain control. This closed-loop system aims to provide more consistent and effective relief, which could be a game-changer for those who have not found success with existing options.
What evidence suggests that closed-loop spinal cord stimulation is effective for chronic pelvic pain?
Research has shown that a new type of spinal cord stimulation (SCS), called ECAP-controlled closed-loop SCS, holds promise for treating chronic pelvic pain. In one study, 79% of patients reported at least a 50% reduction in pain after 12 months. Another study found that these patients also experienced a better quality of life and required fewer medications. Over time, pain levels decreased by nearly 70% for those using this closed-loop SCS. This treatment adjusts its stimulation based on real-time feedback, potentially increasing its effectiveness. These findings suggest that this approach could offer significant relief for people suffering from chronic pelvic pain. Participants in this trial will first undergo a trial of the spinal cord stimulator, and if it results in more than a 50% reduction in pain, they will receive an implantable spinal cord stimulator.23567
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Trial Stimulation
Participants undergo a trial of spinal cord stimulator to assess effectiveness
Treatment
Participants receive implantable spinal cord stimulator if trial results in >50% reduction in pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ECAP-controlled Closed-Loop Spinal Cord Stimulation
How Is the Trial Designed?
1
Treatment groups
Experimental 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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
Citations
ECAP-Controlled Closed-Loop Spinal Cord Stimulation for ...
Results: At 12 months, 79% of patients reported ≥50% reduction in pain intensity and 48% obtained ≥80% pain relief. Significant improvements in ...
Targeting the Conus Medullaris With ECAP-Controlled ...
The aim of the study is to evaluate the effectiveness of using ECAP (electrically evoked compound action potential)-controlled CL (closed-loop) SCS (spinal ...
Closed-Loop Spinal Cord Stimulation in Chronic Pain ...
Patients receiving closed-loop stimulation reported significantly higher rates of sustained pain reduction, improved quality of life, and fewer ...
Disease applications of spinal cord stimulation: Chronic ...
Overall, this study reported a 70 % success rate for trial-to-implant ratio and clinically significant pain relief in most patients followed to 12 months.
5.
asra.com
asra.com/docs/default-source/events-education-documents/pm23/abstract-4942.pdf?sfvrsn=1ee708dd_1ECAP-CONTROLLED CLOSED-LOOP SCS FOR THE ...
Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial.
Closed-Loop Spinal Cord Stimulation in Chronic Pain ... - PMC
Patients receiving closed-loop stimulation reported significantly higher rates of sustained pain reduction, improved quality of life, and fewer ...
7.
ctv.veeva.com
ctv.veeva.com/study/targeting-the-conus-medullaris-with-ecap-controlled-closed-loop-scs-for-treatment-of-chronic-pelvicTargeting the Conus Medullaris With ECAP-Controlled Closed ...
Evaluate safety of using ECAP-controlled CL-SCS in treating chronic pelvic pain. Summarize and evaluate device performance and typical ...
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